Effects of Laughter Therapy on Postpartum Mothers' Stress, Sleep, and Breastfeeding
NCT ID: NCT06851286
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
NA
120 participants
INTERVENTIONAL
2025-02-10
2025-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Laughter Therapy on Marital Adjustment, Life Satisfaction and Maternal Attachment Level in Mothers
NCT06917417
The Effect of Laughter Yoga on the Anxiety and Stress Levels of Women in the Postpartum Period
NCT05345067
MBSR and NLP, Postpartum Breastfeeding and Depression
NCT06628986
The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women
NCT06811298
The Effect of WhatsApp-Based Education and Counseling on Breastfeeding Self-Efficacy, Body Satisfaction, Healthy Lifestyle Behaviors, and Weight Retention in Postpartum Women: A Randomized Controlled Trial
NCT07185906
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In conclusion, laughter is a human and universal value. Using laughter effectively to improve well-being and facilitate adaptation to the changes experienced in this period can significantly improve quality of life. Mothers in the postpartum period need low-cost, easily accessible preventive interventions to prevent these problems. However, to achieve this, health professionals need to be aware of the most appropriate evidence-based interventions. The number of studies investigating the effect of laughter therapy on women's health is limited in Turkey. In order to increase evidence-based data, there is a need to investigate the potential effectiveness of laughter therapy interventions in terms of women's health. In this context, the aim of this study was to determine the effect of laughter therapy given to mothers in the postnatal period on perceived stress, sleep quality and breastfeeding self-efficacy level. It is thought that the results of this study will guide midwives to be aware of the effectiveness of laughter therapy and to plan interventions to improve the quality of life of mothers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
laughter therapy group
After randomization is achieved, a WhatsApp group will be established with the mothers in the laughter therapy group. Before starting the application, the "Zoom" program will be downloaded to the phones or computers of the mothers in the laughter therapy group. Afterwards, an online application will be carried out in groups via Zoom, by determining a common day and time according to the working hours of the mothers and the researcher. Groups will be formed with at least 5-10 people, and laughter therapy will be applied to the groups for 4 weeks, 2 sessions per week, for a total of 8 sessions.
Laughter Therapy
A laughter yoga session; It is approximately 30 minutes and consists of four parts. These sections; hand clapping and warm-up exercises, deep breathing exercises, childish games and laughter exercises. In each laughter yoga session, the first three parts are the same, but the laughter exercises in the fourth part vary. In the first session of each new group, the introduction of laughter yoga, its purpose and objectives will be discussed. 10 minutes will be allocated for this section in the first session of each group. Therefore, the first session is planned to be 40 minutes in each group and all subsequent sessions are planned to be 30 minutes.
control group
No intervention will be made to the control group, they will be asked to fill out the survey forms simultaneously.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laughter Therapy
A laughter yoga session; It is approximately 30 minutes and consists of four parts. These sections; hand clapping and warm-up exercises, deep breathing exercises, childish games and laughter exercises. In each laughter yoga session, the first three parts are the same, but the laughter exercises in the fourth part vary. In the first session of each new group, the introduction of laughter yoga, its purpose and objectives will be discussed. 10 minutes will be allocated for this section in the first session of each group. Therefore, the first session is planned to be 40 minutes in each group and all subsequent sessions are planned to be 30 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Over the age of 18
* Those who volunteer to participate in the research
* Heterosexual
* Having a single and healthy baby
* Postpartum 1-12 month old baby
* Women who can use Zoom program
Exclusion Criteria
* Those with hearing and visual impairments,
* Those with mental disabilities,
* Those diagnosed with a known psychiatric disease,
* Mothers who do not breastfeed
* Mothers who have babies with disabilities and chronic health problems
* Women with physical conditions that prevent them from participating in laughter yoga sessions (respiratory distress, persistent cough, vertiligo, severe heart disease, hemorrhoids, any type of hernia such as neck, waist or inguinal hernia, severe back pain, urinary incontinence, epilepsy, etc.),
* Women who use medication or use another non-pharmacological method to reduce stress.
Women who develop an acute health problem in themselves or their babies, who have a sudden hospitalisation of the mother or baby, mothers who lose their babies, women who do not attend all of the laughter therapy sessions and women who cannot be reached after the application will be excluded from the study.
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Selcuk University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Havva Tokgöz Kekeç
PhD Student, Msc Midwife
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Selçuk University Faculty of Medicine Hospital
Konya, Selçuklu, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Akın, B., Tanyer, D. (2021). SPIRIT 2013 Bildirisi: Klinik Deneyler İçin Standart Protokol Maddelerinin Tanımlanması. HUHEMFAD, 8(1):117-2.
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.
Zhao J, Yin H, Zhang G, Li G, Shang B, Wang C, Chen L. A meta-analysis of randomized controlled trials of laughter and humour interventions on depression, anxiety and sleep quality in adults. J Adv Nurs. 2019 Nov;75(11):2435-2448. doi: 10.1111/jan.14000. Epub 2019 May 9.
Yim J. Therapeutic Benefits of Laughter in Mental Health: A Theoretical Review. Tohoku J Exp Med. 2016 Jul;239(3):243-9. doi: 10.1620/tjem.239.243.
Werner-Bierwisch T, Pinkert C, Niessen K, Metzing S, Hellmers C. Mothers' and fathers' sense of security in the context of pregnancy, childbirth and the postnatal period: an integrative literature review. BMC Pregnancy Childbirth. 2018 Dec 4;18(1):473. doi: 10.1186/s12884-018-2096-3.
Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
van der Wal CN, Kok RN. Laughter-inducing therapies: Systematic review and meta-analysis. Soc Sci Med. 2019 Jul;232:473-488. doi: 10.1016/j.socscimed.2019.02.018. Epub 2019 Mar 5.
Stremler, R., Sharkey, K.M., & Wolfson, A.R. (2017). Postpartum period and early motherhood. In M. Kryger, T. Roth, &W. Dement (Eds.), Principles and practice of sleep medicine (6th ed., pp. 1547Y1552). Philadelphia, PA: Elsevier.
Pierce M, Hope HF, Kolade A, Gellatly J, Osam CS, Perchard R, Kosidou K, Dalman C, Morgan V, Di Prinzio P, Abel KM. Effects of parental mental illness on children's physical health: systematic review and meta-analysis. Br J Psychiatry. 2020 Jul;217(1):354-363. doi: 10.1192/bjp.2019.216.
Okun ML, Mancuso RA, Hobel CJ, Schetter CD, Coussons-Read M. Poor sleep quality increases symptoms of depression and anxiety in postpartum women. J Behav Med. 2018 Oct;41(5):703-710. doi: 10.1007/s10865-018-9950-7. Epub 2018 Jul 20.
Namazinia M, Mazlum SR, Mohajer S, Lopez V. Effects of laughter yoga on health-related quality of life in cancer patients undergoing chemotherapy: a randomized clinical trial. BMC Complement Med Ther. 2023 Jun 12;23(1):192. doi: 10.1186/s12906-023-04028-2.
Moon H, Journ S, Lee S. Effect of Laughter Therapy on Mood Disturbances, Pain, and Burnout in Terminally Ill Cancer Patients and Family Caregivers. Cancer Nurs. 2024 Jan-Feb 01;47(1):3-11. doi: 10.1097/NCC.0000000000001162. Epub 2022 Dec 11.
Meier M, Wirz L, Dickinson P, Pruessner JC. Laughter yoga reduces the cortisol response to acute stress in healthy individuals. Stress. 2021 Jan;24(1):44-52. doi: 10.1080/10253890.2020.1766018. Epub 2020 May 26.
Küçükkelepçe, D. Ş., Ünver, H., & Kurt, N. (2024). Kahkaha Yogasının Emzirme Öz-Yeterliliği Üzerine Etkisinin İncelenmesi: Randomize Kontrollü Çalışma. Journal of Academic Research in Nursing, 10(1), 57-66. https://doi.org/10.55646/jaren.2024.93064
Konukbay D, Oksuz E, Guvenc G. Breastfeeding self-efficacy in terms of sleep quality, perceived social support, depression and certain variables: a cross-sectional study of postpartum women in Turkey. BMC Pregnancy Childbirth. 2024 Apr 2;24(1):231. doi: 10.1186/s12884-024-06456-5.
Ko Y, Park S. A pilot randomized controlled trial of distance laughter therapy for mothers' level of depression, anxiety, and parental stress during the COVID-19 pandemic. PLoS One. 2023 Jul 14;18(7):e0288246. doi: 10.1371/journal.pone.0288246. eCollection 2023.
Khadka R, Hong SA, Chang YS. Prevalence and determinants of poor sleep quality and depression among postpartum women: a community-based study in Ramechhap district, Nepal. Int Health. 2020 Feb 12;12(2):125-131. doi: 10.1093/inthealth/ihz032.
Henrique AJ, Gabrielloni MC, Rodney P, Barbieri M. Non-pharmacological interventions during childbirth for pain relief, anxiety, and neuroendocrine stress parameters: A randomized controlled trial. Int J Nurs Pract. 2018 Jun;24(3):e12642. doi: 10.1111/ijn.12642. Epub 2018 Mar 7.
Harputlu D, Ozturk FO, Aydin D, Akyol C, Tezel A. Effect of Laughter Yoga on Sleep and Quality of Life in Individuals With Fecal Ostomies: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2023 Jul-Aug 01;50(4):307-312. doi: 10.1097/WON.0000000000000988.
Dominguez-Solis E, Lima-Serrano M, Lima-Rodriguez JS. Non-pharmacological interventions to reduce anxiety in pregnancy, labour and postpartum: A systematic review. Midwifery. 2021 Nov;102:103126. doi: 10.1016/j.midw.2021.103126. Epub 2021 Aug 14.
Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Christian LM, Carroll JE, Porter K, Hall MH. Sleep quality across pregnancy and postpartum: effects of parity and race. Sleep Health. 2019 Aug;5(4):327-334. doi: 10.1016/j.sleh.2019.03.005. Epub 2019 May 20.
Cattarius BG, Schlarb AA. How the Sleep of Couples Changes from Pregnancy to Three Months Postpartum. Nat Sci Sleep. 2021 Feb 24;13:251-261. doi: 10.2147/NSS.S259072. eCollection 2021.
Bilge A., F, Öğce., Genç, R. E., Oran, N.T. (2009). Algılanan Stres Ölçeği (ASÖ)'nin Türkçe Versiyonunun Psikometrik Uygunluğu, Ege Üniversitesi Hemşirelik Yüksekokulu Dergisi, 2(25), 61-72, 2009.
Alus Tokat M, Okumus H, Dennis CL. Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. Midwifery. 2010 Feb;26(1):101-8. doi: 10.1016/j.midw.2008.04.002. Epub 2008 Jun 9.
Agapinar Sahin S, Bekar M. The influence of laughter yoga on pregnancy symptoms, mental well-being, and prenatal attachment: A randomized controlled study. Health Care Women Int. 2023 Jun;44(6):782-801. doi: 10.1080/07399332.2022.2164284. Epub 2023 Jan 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Researcher
Identifier Type: OTHER
Identifier Source: secondary_id
2024/616
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.