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Postnatal CareNCT06851286

Effects of Laughter Therapy on Postpartum Mothers' Stress, Sleep, and Breastfeeding

A study testing Laughter Therapy in people with Postnatal Care and Lactation, run by Selcuk University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Postnatal period is an important developmental transition period for women. Stress in the postnatal period is one of the most common mental health problems and most mothers report experiencing stress in the perinatal period. In addition, stress and negative mental health also threaten breastfeeding self-efficacy. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Postnatal Care, Lactation
What is being tested?
Laughter Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Feb 2025to 30 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least primary school graduate
  • 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

Who cannot join

  • Those who do not speak Turkish,
  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

  • Selçuk University Faculty of Medicine Hospital

    Konya, Selçuklu, 42250

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Laughter Therapy Given to Mothers in The Postpartum Period on Their Perceived Stress, Sleep Quality and Breastfeeding Self-Efficacy Level; Randomized Controlled Trial

Postnatal period is an important developmental transition period for women. Stress in the postnatal period is one of the most common mental health problems and most mothers report experiencing stress in the perinatal period. In addition, stress and negative mental health also threaten breastfeeding self-efficacy. The postnatal period is an important stage in terms of early initiation and maintenance of breastfeeding. Breastfeeding self-efficacy is a mother's perceived confidence in her ability to breastfeed her newborn baby. Therefore, midwives are expected to assess women and identify women in need of supportive interventions and consciously contribute to their treatment. Another common problem in the postnatal period is poor sleep quality. It was determined that an increase in sleep quality and perceived social support positively affected breastfeeding self-efficacy of postpartum women. In addition, poor sleep quality poses a threat for negative mental health outcomes for women in the postpartum period. Previous studies reflect mothers' desire for non-pharmacological interventions and a high degree of satisfaction with these therapies. Laughter therapy, one of the main non-pharmacological interventions, is recognised as a universal approach to reduce stress and anxiety. The postnatal period is a fragile period with physical and psychological changes as well as hormonal changes in the mother. Poor mental health of the mother poses a danger to the well-being of the mother and the baby. Mothers in the postpartum period need low-cost, easily accessible preventive interventions to prevent these problems. In this context, the aim of this study is to determine the effect of laughter therapy given to mothers in the postpartum period on perceived stress, sleep quality and breastfeeding self-efficacy level in mothers.

Read the detailed description

The postnatal period is an important developmental transition period for women and mothers experience various difficulties. Therefore, midwives are expected to assess women and identify women in need of supportive interventions and consciously contribute to their treatment. Previous studies reflect mothers' desire for non-pharmacological therapies and a high degree of satisfaction with these therapies. Laughter therapy, one of the main non-pharmacological interventions, is recognised as a universal approach to reduce stress and anxiety. Laughter therapy is a new, simple, cost-effective, non-invasive, non-invasive, widely available online, easily accessible and effective method. Laughter therapy has been applied to many different patient populations and healthy individuals in a variety of settings, and studies have reported benefits such as improved sleep quality, decreased depression, pain and stress hormones, improved mood and life satisfaction, increased prenatal attachment and breastfeeding self-efficacy. These benefits document the positive role of laughter therapy in improving the quality of life of individuals. Laughter therapy is a type of cognitive-behavioural therapy that can improve physical, psychological and ultimately quality of life. Laughter therapy can be used for both preventive and therapeutic purposes. In contrast, the negative effects of laughter and humour are negligible.

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.

Being tested
Laughter Therapy
Keywords
Sleep Quality, Breastfeeding Self-Efficacy Level, Laughter Therapy, Perceived Stress
Medical subject headings
Breast Feeding, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laughter TherapyBehavioural

    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.

Study groups in NCT06851286
Study groupRoleWhat they receive
laughter therapy groupExperimentalAfter 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.
Receives: Behavioral: Laughter Therapy
control groupNo interventionNo intervention will be made to the control group, they will be asked to fill out the survey forms simultaneously.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Scale

    It was developed by Cohen, Kamarck \& Mermelste (1983), and in the reliability study, the Cronbach Alpha value was found to be 0.86. The Cronbach Alpha value of the "Perceived Stress Scale", which was adapted into Turkish by Bilge, Öğce, Genç and Oran (2007) and whose validity and reliability studies were conducted, was found to be 0.81. Three items of the scale, prepared in a 5-point Likert type (0 never, 4 very often), are reverse-worded (items 4, 5, 6), and five items are literal (items 1, 2, 3, 7, and 8). A total score of 0-32 is taken from the scale. It has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, and 6). The scale is evaluated on both total score and subscale scores. A high total score means a high perceived stress level. High scores from the subscales are a negative situation.

    Measured: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60

Secondary outcomes (1)

  1. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI was developed by Buysse et al. (1989) (20) and its Turkish validity and reliability was performed by Ağargün et al. (1996). The PSQI provides information about sleep quality in the last month and the type and severity of sleep disturbance. In the scale consisting of 24 questions in total, 18 questions are scored. The scale consists of 7 sub-dimensions that provide information about the individual's 'Subjective Sleep Quality', 'Sleep Latency', 'Sleep Duration', 'Habitual Sleep Efficiency', 'Sleep Disorder', 'Sleep Medication Use' and 'Daytime Dysfunction'. Each sub-dimension is evaluated on a 0-3 point scale (item 0=no distress, 3=serious distress). The total score of all sub-dimensions gives the total score of the scale (min- max=0-21). Sleep quality is classified as good between 0-4 points and poor sleep quality between 5-21 points.

    Measured: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start10 Feb 2025
  3. Primary completion15 Apr 2025 (estimated)
  4. Study completion30 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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. No intervention will be made to the control group, and they will be asked to fill out the survey forms simultaneously. 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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06851286
Sponsor's protocol ID
2024/616
Other IDs
Researcher
Status last verified
Feb 2025
First submitted
16 Feb 2025
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2748771

  • 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.

    PubMed 28630973

  • 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.

    PubMed 30882915

  • 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.

    PubMed 27439375

  • 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.

    PubMed 30509217

  • 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.

    PubMed 26869575

  • 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.

    PubMed 31029483

  • 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.

    PubMed 31610824

  • 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.

    PubMed 30030650

  • 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.

    PubMed 37303065

  • 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.

    PubMed 36066344

  • 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.

    PubMed 32393092

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Laughter Therapy in people with Postnatal Care and Lactation, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Scale (time frame: 1st Time: Day 1, 2nd Time: Day 30, 3rd Time: Day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06851286, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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