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

NCT06851286 | Enrolling By Invitation

• 2 other identifiers: 2024/616Researcher
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postnatal Care; Lactation

Keywords

Sleep Quality; Breastfeeding Self-Efficacy Level; Laughter Therapy; Perceived Stress

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

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

Other Outcomes (1)

• Breastfeeding Self-Efficacy Scale

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

Study Arms (2)

laughter therapy group

EXPERIMENTAL

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.

Behavioral: Laughter Therapy

control group

NO INTERVENTION

No intervention will be made to the control group, they will be asked to fill out the survey forms simultaneously.

Interventions

Laughter Therapy BEHAVIORAL

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.

laughter therapy group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: breastfeeding mothers in the postpartum period
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selçuk University Faculty of Medicine Hospital

Konya, Selçuklu, 42250, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Breast Feeding; Sleep Initiation and Maintenance Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the study, the process of assigning mothers to the laughter therapy and control groups was done by simple randomisation to ensure similarity between the groups. To ensure randomisation in the study, a table of random numbers was created by dividing into two groups according to the number determined on https://www.randomizer.org/. Two random number series (set 1 and set 2) between 1- 120 were created in the system using the Random Integer Generator method in the Numbers subheading of this site. The 120 women who met the inclusion criteria were assigned to 60 laughter therapy groups and 60 control groups in a 1:1 ratio by simple randomisation method. Which group was the intervention or control group was determined by drawing lots at the beginning of the study. The mothers included in the study did not know which group they were in at first. After the individuals who met the inclusion criteria and volunteered to participate in the study were determined, the participants were assigned
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Msc Midwife

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 28, 2025
• Study Start: February 10, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)