INTRODUCTION
1. Study Rationale
According to the epidemiological survey on mental disorders conducted by the Korean Ministry of Health and Welfare, one in four adults experiences a mental health issue at least once in their lifetime, with a lifetime prevalence of mental disorders of 22.9% among women [
1]. By age bracket, the prevalence of mental disorders among women in their 40s and 50s is 22.4% and 23.0%, respectively [
1]. Given that middle-aged women represent a substantial segment of the population and often serve pivotal roles as wives and mothers, their mental well-being warrants particular attention.
Unlike in pre-modern times, modern middle-aged women benefit from higher levels of education, improved economic status, increased opportunities for societal engagement, evolving social status and values, lower fertility rates, and technological advancements in household management. Nevertheless, they remain vulnerable to mental health risks due to ongoing responsibilities related to child-rearing, household duties, and male-dominated organizational structures [
2]. Furthermore, they face psychological challenges associated with aging, hormonal changes, and menopause, highlighting the need for tailored nursing interventions for middle-aged women with mental health disorders.
Korea has long grappled with culturally ingrained social prejudice and stigma surrounding mental illness, which has contributed to reluctance among individuals to seek professional help or adhere to ongoing treatment after diagnosis [
3]. Effective intervention for mental illness requires active participation and compliance with treatment protocols by patients [
1]. However, individuals with mental disorders tend to avoid medication more frequently than those with physical ailments [
4]. The utilization rate of mental health services in Korea is strikingly low, at 7.2%(as of 2021), in stark contrast to the 43.1% in the US (2015), 46.5% in Canada (2014), and 34.9% in Australia (2009)[
1]. Poor treatment adherence can lead to a series of adverse outcomes, including relapses, frequent hospitalizations or emergency room visits, diminished life satisfaction, occupational difficulties, and, in severe cases, suicide attempts [
5]. Therefore, it is imperative to develop and implement strategies that enhance treatment adherence to both medication regimens and psychosocial rehabilitation therapies to facilitate the recovery and rehabilitation of individuals with mental disorders.
A positive attitude toward medication is known to improve treatment adherence [
5,
6]. To increase medication adherence, patients must learn to accept negative emotions, experience the satisfaction of achieving positive goals, and be proactive managers of their disease [
7]. Attitudes toward medication and self-efficacy are key factors that increase medication adherence [
5]. Hope, as a psychological resource, enables individuals to persevere through adversity and failure [
8], while self-efficacy, which drives positive actions during critical situations, is a strong predictor of subjective well-being [
9]. Therefore, hope and self-efficacy are key in helping psychiatric patients recover more effectively from illness by enabling them to choose and maintain beneficial actions [
7].
This reasoning underscores the importance of interventions aimed at instilling hope, such as laughter therapy programs that promote positive emotions by mitigating the negative aspects of mental illness. These programs can also simultaneously enhance self-efficacy by setting achievable goals tailored to each patient’s unique history, ultimately increasing medication adherence and improving overall treatment outcomes. Further, maintaining a balance between physical and mental well-being in middle age is crucial for ensuring a healthier and happier old age. Poorly managed chronic conditions in their early stages can significantly degrade quality of life and lead to various difficulties for families [
6]. This underscores the need for the development of targeted intervention programs that enhance treatment adherence, particularly for psychiatric patients. Greater attention should be paid to nursing interventions tailored to middle-aged women with psychiatric conditions.
The physiological benefits of laughter include reduced levels of stress hormones, such as cortisol and epinephrine, and increased levels of health-promoting hormones, such as endorphins [
10,
11]. Moreover, compared to other types of therapies (e.g., aroma therapy, story therapy), laughter therapy can be easily implemented in diverse settings with minimal training [
10]. While most laughter therapy studies have focused on older populations, examining issues such as mental health [
12], depression, quality of life, physical health in older women [
13], stress and healthy aging [
14], and cognitive and mental health in older adults [
15], some have explored its effects on stress levels and health indicators in middle-aged women [
16]. Nevertheless, research focusing specifically on the middle-aged population remains limited. Furthermore, while these studies have reported on the efficacy of laughter therapy programs in promoting mental health and eliciting positive physical and psychological responses, no study has yet explored their impact specifically on middle-aged female psychiatric inpatients.
Against this backdrop, this study aimed to develop and implement a laughter therapy program tailored to middle-aged female psychiatric inpatients. The program focused on enhancing their hope and self-efficacy, with the goal of improving their mental health outcomes and medication adherence. The overarching objective of this research is to provide robust scientific evidence supporting the efficacy of laughter therapy as an intervention that bolsters self-management capabilities, which are crucial for the successful reintegration of patients into social life.
2. Study Objectives
This study aimed to develop, implement, and assess the efficacy of a laughter therapy program tailored to middle-aged female psychiatric inpatients. The program’s effectiveness was assessed by specifically examining its impact on three dependent variables: hope, self-efficacy, and medication adherence among the study population.
3. Research Hypotheses
To evaluate the program’s effectiveness, we formulated the following hypotheses:
• H1: Participants in the laughter therapy program demonstrate a significant increase in hope scores compared to the control group not exposed to the intervention.
• H2: Participants in the laughter therapy program demonstrate a significant increase in self-efficacy scores compared to the control group not exposed to the intervention.
• H3: Participants in the laughter therapy program demonstrate a significant increase in medication adherence scores compared to the control group not exposed to the intervention.
METHODS
1. Research Design
We employed a quasi-experimental approach using a non-equivalent control group pretest-posttest design.
Table 1 provides a comprehensive overview of the research design.
2. Participants
The study participants comprised middle-aged women (aged between 40 and 60) admitted with mental disorders to the psychiatric wards of a hospital located in K province. All participants were given detailed explanations of the purpose and procedure of the study, after which they voluntarily agreed to participate. The inclusion criteria were middle-aged women without acute psychotic symptoms (hallucinations or delusions) or behavioral disorders (self-harm, harm to others, or aggression), who were capable of communication and had unimpaired judgment and reality perception. Individuals with organic mental disorders or intellectual disabilities and those not taking antipsychotic drugs were excluded from the study. Additionally, all participants were undergoing conventional treatments in the ward, including group therapy, recreational activities, and psychosocial interventions.
The required sample size was calculated using the G* Power 3.1.7 program [
17]. Based on prior research, we assumed an effect size of 0.80, a power of 80%, and a significance level of 0.05. Thus, we determined that 26 participants each were needed for the experimental and control groups (52 participants in total). Considering dropout rates from previous studies on programs for psychiatric inpatients [
18,
19], we decided to recruit 30 participants per group. Recruitment was conducted by posting the recruitment notice on the bulletin board of the target ward. Interested individuals signed up by filling out an application form available in the ward. We ensured all participants met the inclusion criteria through communication with psychiatrists and medical staff. This study was completed successfully without any dropouts, with data collected from all 60 participants.
3. Research Instruments
1) Hope
Hope was measured using the Hope Scale originally developed by Nowotny [
20] for cancer patients and adapted by Kim for use in a Korean population [
21]. We further adjusted the items to make them suitable for psychiatric patients. The scale consists of 15 questions across several subdomains: confidence, relates to others, future is possible, spiritual beliefs, active involvement, and comes from within. Responses are rated on a 4-point Likert scale, with higher total scores indicating higher levels of hope. The tool’s reliability, measured by Cronbach’s ⍺, was .86 in Kim’s study [
21] and .87 in our study.
2) Self-efficacy
Self-efficacy was measured using the Self-efficacy Scale developed by Kim and Cha [
22]. This 24-item tool comprises three domains: confidence, self-regulatory efficacy, and task difficulty. Respondents rate each item on a 5-point Likert scale, with higher total scores indicating greater levels of self-efficacy. The tool’s reliability, as measured by Cronbach’s ⍺, was .88 in Kim and Cha’s original study [
22] and .87 in our study.
3) Medication adherence
Medication adherence was measured using the Korean version of the Medication Adherence Rating Scale (KMARS), originally developed by Thompson et al.[
23] and adapted and standardized for psychiatric patients by Chang et al. [
24]. The KMARS consists of 10 questions across three subfactors: attitude toward taking medications, adherence behavior, and response to medications. Each item is scored as either 0 or 1, with 0 indicating nonadherence and 1 indicating adherence. Higher total scores represent higher adherence rates. The tool’s reliability, as measured by Cronbach’s ⍺, was .71 in Chang et al.’s study [
24] and .65 in this study.
4. Research Procedure
1) Laughter therapy program
The program designed for the current study adhered to the content validity criteria established by Lynn [
25]. The program’s content validity was assessed using the Content Validity Index (CVI)[
26]. The CVI is particularly well-suited for a 4-point scale, eliminating the ambiguity of a mid-point evaluation option. In applying the CVI, the scores were defined as follows: 1=not relevant, 2=unable to assess relevance or needs significant revision, 3=relevant but needs minor revision, and 4=very relevant.
For content validation, it is recommended to employ a panel of 3~10 experts [
25]. Accordingly, we assembled a panel of three laughter therapy experts and two psychiatric nurses to review and evaluate the program’s validity. We subsequently revised the program based on their feedback. To ensure an objective validity assessment based on structured instruments, we provided the expert panel with guidelines and relevant literature to determine the relevance of the domain and item contents [
27]. Additionally, we included a section for open-ended comments at the end of the evaluation form to systematically refine the program based on the experts’ qualitative feedback [
25].
All items scored 3 or higher on the CVI. Moreover, the experts offered the following suggestions: “An understanding of laughter therapy is necessary in the early stages,” “Since the patients are in psychiatric wards, hospital approval is needed before proceeding with the program,” and “The program should include practical aspects of medication adherence to induce behavioral changes.” Accordingly, we adjusted the program to begin with an introduction to laughter to help participants understand the concept of laughter therapy. Additionally, participants were required to consult their primary care physicians or specialists to confirm their suitability for the group activity program. Arrangements were also made with the hospital to allow participants to withdraw if they experienced psychological discomfort and to talk to psychiatric nurses if necessary (though no such occasion arose). To enhance medication adherence, we incorporated practical tasks into the program, enabling participants to apply what had they learned and share their experiences in each session.
A meta-analysis comparing the effect sizes of different laughter therapy programs revealed that a four-stage structure-comprising preparation, introduction, main, and outro stages-was more effective than a three-stage program [
28]. Based on this finding, the laughter therapy program in this study followed the four-stage format. In the preparation stage, participants were introduced to the session's topic and goals, fostering a relaxed atmosphere with laughter greetings to naturally initiate the therapy. In the introduction stage, the elements of the laughter treatment program were presented, aligning them with the session’s main topic. The main stage employed laughter techniques designed to elicit deep laughter. In the outro stage, the session ended with positive feedback and words of praise to uplift participants’ moods. The laughter treatment program emphasizes progressive, repetitive, and continuous laughter training, with at least four weeks of practice needed to sustain laughter by fostering positive changes in mindsets, expressions, and thoughts.
The finalized program consisted of eight 60-minute sessions, held twice a week. The sessions were structured as follows: Session 1: Theory and Understanding of Laughter; Sessions 2 and 3: Self-efficacy; Sessions 4 and 5: Medication Adherence; Sessions 6 and 7: Hope; and Session 8: Wrap-up. The program sessions and contents are detailed in
Table 2.
2) Data collection
After obtaining approval from the hospital’s director, a recruitment notice for the program was posted on the ward’s bulletin board for one week. Interested individuals completed the application form available in the ward. Those who completed the form were screened by a psychiatric nurse to confirm their diagnosis. Subsequently, the patients’ primary care physicians or specialists were consulted to assess their severity of hallucinations and delusions, risk of self-harm and aggression, level of cognitive function, and suitability for participation in a group activity program.
To prevent contamination of the control group, the experimental and control groups were recruited and underwent the pretest, posttest, and intervention in their respective wards located in separate buildings. The experimental group participated in an eight-session program, with each session lasting 60 minutes, conducted twice a week from June 10 to July 1, 2023. Interested participants in the control group were provided with the opportunity to receive the intervention (workbook and program) upon completion of the experimental group’s data collection.
The experimental group was encouraged to participate through the provision of light refreshments during the program sessions. Throughout the intervention period, this group continued to receive routine care and medication therapy and participated in usual ward activities but did not engage in any other activity therapies. The posttest for both groups was conducted four weeks after the pretest, applying the same location, environment, time, methods, and procedures as the pre-test. The questionnaire took approximately 15 minutes to complete. The experimental and control groups were given a thank-you gift after participation.
5. Ethical Considerations
This study was conducted with approval from the Institutional Review Board of A Institution (IRB No. AN01-202303-HR-002-01). To ensure the ethical protection of participants during data collection, explanations about the study were provided prior to the consent procedure. Given their status as psychiatric patients, informed consent was obtained from both the participants and their legal representatives (caregivers) with the assistance of ward nurses. Initial verbal consent was obtained via telephone, followed by written consent.
Participants were encouraged to respond independently. However, if assistance was required, a psychiatric nurse with over five years of experience read the questions aloud and recorded the responses, ensuring ethical standards were maintained throughout the process. In addition, participants were informed that they could withdraw from the program at any time, and that there were no disadvantages upon withdrawal. All survey data were coded and stored on a password-protected hard drive accessible only to the researcher. Data management was conducted in strict compliance with the Personal Information Protection Act to safeguard participants’ privacy and confidentiality.
6. Data Analysis
Data analysis was conducted using the SPSS/WIN 20.0 statistical software package. The reliability of the psychometric tools was evaluated using Cronbach’s ⍺ coefficients. The Kolmogorov-Smirnov and Shapiro-Wilk tests confirmed that the dependent variables met the assumption of normality, allowing for the use of parametric statistical methods to analyze differences between the experimental and control groups. The statistical significance level was set at p<.05.
Homogeneity of general characteristics and dependent variables between the experimental and control groups was assessed using frequencies and percentages. This homogeneity was verified using x2 tests, Fisher’s exact tests, and independent t-tests, as appropriate. To examine the effects of the laughter therapy program on hope, self-efficacy, and medication adherence in the experimental and control groups, independent t-tests were employed.
DISCUSSION
In this study, a laughter therapy program was developed for middle-aged female psychiatric inpatients to increase hope-representative of positive emotion-and self-efficacy, which is closely linked to hope as a motivational factor, with the ultimate goal of improving medication adherence among these patients. The effects of the laughter therapy program on these three dependent variables are further explained in this section.
First, the experimental group that received the laughter therapy program scored significantly higher in hope than the control group. This finding is notable, as hope is an essential factor in the rehabilitation of psychiatric patients and is associated with the formation of a positive self-perception, which can serve as a turning point in their recovery. While direct comparisons are limited owing to the scarcity of studies on laughter therapy programs for middle-aged female psychiatric inpatients, similar findings have been reported in related contexts. For example, Koh and Hyun [
9], who examined the effects of a positive psychology program among patients with depressive disorders, reported significant increases in hope scores and decreases in depression scores in the experimental group. They explained that hope, as a positive emotion, reduces depressive symptoms and enhances positive coping skills. Similarly, a study by Park and Park [
7] on psychiatric patients demonstrated that a hope enhancement program significantly increased hope and enhanced quality of life in the experimental group when compared to the control group.
Kim and Lee [
29], who analyzed the hope levels of psychiatric patients in Korea, found that the more severe the symptoms, the lower the hope level. They also observed that when psychiatric patients positive perceived the program positively, as opposed to being in an authoritative or coercive treatment environment, their hope increased. This aligns with the structure of the laughter therapy program in this study, wherein each session began with laughter greetings and ended with laughter of gratitude and praise, which provided participants opportunities for positive emotional experiences, likely contributing to enhanced hope.
Laughter therapy elicits positive emotions, triggering hormonal changes and activating the parasympathetic nervous system, thus leading to scientifically demonstrated stress relief and boosting immunity [
12,
16]. Laughter therapy has also shown significant effects on depression [
13], mental health [
12], and quality of life [
13], with hope identified as a key element in promoting positive changes in psychotherapy [
8]. However, despite the increasing interest in evaluating the effects of positive emotions like hope in treatment, nursing interventions developed for psychiatric patients are lacking [
12]. This highlights the need for the continued development of programs to enhance hope in psychiatric patients through laughter therapy, which has the advantages of no side effects and easy implementation in various settings.
Second, the experimental group that received the laughter therapy program scored significantly higher in self-efficacy than the control group. Upon completion of the laughter therapy program, certificates of completion were awarded to all participants who diligently attended all eight sessions, which likely promoted their self-efficacy. Moreover, feedback from participants after completing the program included comments such as, “I looked forward to the laughter therapy program every week,” “I am grateful to the instructor for providing a time to laugh during my long hospital stay,” and “Time flew by while laughing.” This feedback suggests that the program provided opportunities for positive perceptual and behavioral changes.
The finding regarding self-efficacy is supported by previous research. For example, Koh and Hyun [
9] found a positive psychology program significantly increased self-esteem in patients with depressive disorders. They proposed that hope is a goal-oriented thought process involving strong willpower for goal setting and pursuit, as well as the motivation and determination to achieve these goals. Similarly, Park and Park [
7] found that a hope enhancement program increased self-efficacy scores. They attributed this increase to the program’s ability to transform chronic pessimistic beliefs associated with mental illness into hope through cognitive restructuring, thereby fostering a positive self-perception.
Lee and Kim [
5] pointed out the absence of a self-efficacy scale for medication adherence tailored to psychiatric patients, highlighting the need to develop such a tool, given the importance of self-efficacy as a key predictor of long-term behavioral changes. They argued that it is crucial for psychiatric patients to experience joy in achieving goals best-suited for their individual circumstances and to take active ownership of their condition. Therefore, ongoing development of psychometric instruments and related research on self-efficacy in psychiatric patients are needed.
Third, no significant difference was observed in medication adherence scores between the experimental and control groups. This is consistent with findings by Lee and Kim [
5], who examined the effects of group motivational interviewing compliance therapy. They found significant differences in attitudes toward medication between the experimental and control groups but not in medication adherence scores. They suggested that medication adherence involves behavioral changes that occur not rapidly but over an extended period, emphasizing the need for continuous participation and prolonged program duration. In the current study, the experimental group showed only a marginal increase in medication adherence (from 13.64 to 13.70), indicating that further research should consider the time required for behavioral changes. Given the critical importance of medication adherence among psychiatric patients, there is a compelling need for ongoing development of effective nursing interventions.
Finally, the program promoted interaction and exchange among participants in each session, which contributed to improved hope and self-efficacy, as they experienced a sense of accomplishment in achieving their set goals. Laughter secretes serotonin and endorphins to feel positive [
10], reducing stress, anxiety, tension, and depression, and increasing positive emotions [
10,
12-
14,
16,
30]. This positive outcome highlights the potential of laughter therapy as a valuable nursing intervention for middle-aged women in psychiatric wards. Future efforts should focus on expanding the application of such programs to enhance the hope and self-efficacy of this population.
Three limitations of this study should be noted. First, the effects were measured immediately post-program, without subsequent follow-ups, leaving the long-term impact uncertain. Future research should assess the effects after a specified period to better understand long-term outcomes. Second, as the study was conducted with middle-aged female psychiatric inpatients in a single hospital in K Province, Korea, caution is warranted in generalizing its findings to other populations or settings. Lastly, there was limited control over participants’ diverse psychiatric conditions and medications, which may have influenced the results.