Effect of stimulated laughter therapy through virtual meetings in mothers during the COVID-19 pandemic
| ISRCTN | ISRCTN42122907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42122907 |
- Submission date
- 06/08/2021
- Registration date
- 10/08/2021
- Last edited
- 09/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The impact of the COVID-19 pandemic has radically changed our routines. The global population is suffering from long confinement and the consequent adverse psychological conditions such as depression and anxiety. COVID-19-related changes increase parental care demand and burnout, possibly leading to potential child maltreatment. The aim of this study is to develop and apply stimulated laughter therapy (SLT) to mothers caring for young children during the pandemic and examine its effectiveness at reducing their levels of depression, anxiety and parental stress.
Who can participate?
Mothers caring for children aged under 6 years during the pandemic
What does the study involve?
Participants are randomly allocated to the experimental group who receive four sessions of SLT or a control group who watch a 50-minute entertainment TV show. The SLT program consists of various stimulated laughter techniques followed by facial stretching, such as laughter with clapping, singing, and dancing. Each session is about 50 minutes long. SLT is provided through a virtual meeting method using Zoom (https://zoom.us).
What are the possible benefits and risks of participating?
Participants who complete the study are compensated with 17.33 USD (20,000 KRW). There is minimal risk involved.
Where is the study run from?
Gwangju University (South Korea)
When is the study starting and how long is it expected to run for?
February 2021 to June 2021
Who is funding the study?
1. Chung-Ang University (South Korea)
2. Gwangju University (South Korea)
Who is the main contact?
Dr Sihyun Park
sh8379@cau.ac.kr
Contact information
Scientific
Department of Nursing, Red-Cross College of Nursing
84 Heuk-seok ro, Dong-jak gu
Seoul
06974
Korea, South
| Phone | +82 (0)2 820 5737 |
|---|---|
| sh8379@cau.ac.kr |
Study information
| Study design | Mixed-method randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of stimulated laughter therapy through virtual meetings in mothers during the COVID-19 pandemic in South Korea: a mixed-method randomised controlled trial |
| Study objectives | The purpose of this study is to develop and apply stimulated laughter therapy (SLT) to mothers caring for young children during the pandemic and examine its effectiveness in reducing their levels of depression, anxiety, and parental stress. The specific aims of this study were: 1. To examine the effects after applying SLT in the participants’ levels of depression, state/trait anxiety, and parental stress 2. To understand the participants’ perceived changes and feedback related with SLT. |
| Ethics approval(s) | Approved 06/05/2021, the institutional research board of Chung-Ang University (84 Heuk-seok ro, Dong-jak gu, Seoul, 06974, South Korea; +82 (0)2 820 6236; rsch@cau.ac.kr), ref: 1041078-202103-HRSB-064-01 |
| Health condition(s) or problem(s) studied | Depression, anxiety and parental stress |
| Intervention | One research assistant (RA), not involved in this study, randomly divides 22 participants into an experimental group (n=11) and a control group (n=11) using a research randomizer site (http://www.randomizer.org). Since the study applies the double-blind method, both researchers and participants are blinded to the allocation. Participants are randomised to the experimental group who receive four sessions of SLT or a control group who watch a 50-minute entertainment TV show. The SLT in this study consists of four sessions and is performed twice per week for 2 weeks. It is based on a previous meta-analysis (Kang, 2017) reporting that four-session programs showed a higher effect size than three sessions. The number of sessions per week is considered more important at enhancing the program outcome than the duration of the sessions. Each session of SLT consists of four stages — introduction, implement, wrap-up, and evaluation. The program consists of various stimulated laughter techniques followed by facial stretching, such as laughter with clapping, singing, and dancing. Each session is about 50 minutes long. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Depression measured using the Center of Epidemiologic Studies Depression Scale (CES-D) at baseline and right after the intervention 2. State and trait anxiety measured with State-Trait Anxiety Inventory at baseline and right after the intervention 3. Parental stress assessed using the Korean Parenting Stress Scale at baseline and right after the intervention |
| Secondary outcome measures | Experimental group participants' experiences of the intervention, assessed using a semi-structured questionnaire in an exit phone interview after the intervention |
| Overall study start date | 15/02/2021 |
| Completion date | 15/06/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Women with at least one child aged under 6 years 2. No psychiatric symptoms and medication histories at the time of intervention 3. Able to use Zoom at home |
| Key exclusion criteria | Those with psychiatric symptoms and medication histories at the time of intervention |
| Date of first enrolment | 07/05/2021 |
| Date of final enrolment | 04/06/2021 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Hyodeok-ro 227, Nam-gu
Gwangju
61743
Korea, South
Sponsor information
University/education
84 Heuk-seok ro, Dong-jak gu
Seoul
06974
Korea, South
| Phone | +82 (0)2 820 5672 |
|---|---|
| nursing@cau.ac.kr | |
| Website | http://neweng.cau.ac.kr/ |
"ROR" |
https://ror.org/01r024a98 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- CAU
- Location
- Korea, South
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Kwangju University
- Location
- Korea, South
Results and Publications
| Intention to publish date | 15/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this wasn't approved by the institutional review board. The data are all anonymized and stored in the corresponding author’s computer. The researchers are going to destroy this data after 3 years as approved by the institutional review board. |
Editorial Notes
09/08/2021: Trial's existence confirmed by the institutional research board of Chung-Ang University.
