NCT07794371

Brief Summary

Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. While some women perceive pregnancy as a source of joy and happiness because of the anticipated arrival of a new family member, others may perceive it as a source of worry, anxious anticipation, and stress. In addition to physical and hormonal changes, expectant mothers experience numerous psychological and social changes during pregnancy. A woman's psychological state and experiences may influence the course of pregnancy, while pregnancy itself may also cause significant changes in her psychological state. Women who are unable to adequately adapt to these changes may experience various psychological problems due to pregnancy-related bodily changes and physical complaints, concerns about parenthood, changes in family and social roles, fear of childbirth, unwanted pregnancy and miscarriage, new challenges and needs arising from pregnancy, concerns and worries about the baby, parenting stress, low self-esteem, a persistent tendency toward negative thinking, lack of social support and social isolation, marital and partner-related problems, domestic violence, adverse life experiences, alcohol and tobacco use during pregnancy, chronic diseases, inadequate weight gain during pregnancy, exposure to sexual abuse, employment-related issues, and financial concerns. If these psychological problems arising during pregnancy are not resolved, emotional distress may continue to increase, potentially leading to stress and depression Symptoms of brain fog, such as forgetfulness and absent-mindedness, may occur once or twice during pregnancy or may persist throughout pregnancy. Brain fog may become more pronounced during periods of fatigue or irregular sleep, such as in the early or late stages of pregnancy. Studies conducted among pregnant women have shown that fluctuations in progesterone and estrogen during pregnancy may lead to impairments in attention, memory, and executive functioning because the brain is sensitive to changes in hormone levels. Laughter yoga (Laughter Therapy/Laughter Yoga), developed by Dr. Kataria, is a therapeutic method that combines yogic breathing techniques with laughter exercises. A systematic review reported that laughter yoga physiologically increases oxygenation, relaxes muscles, stimulates circulation and the immune system, increases endorphin release and thereby enhances the pain threshold and pain tolerance, strengthens mental functioning by reducing stress hormone levels, decreases depression and anxiety, improves sleep quality, and promotes psychological well-being by enhancing interpersonal relationships and social interaction. The literature highlights the positive physiological, psychological, and social effects of laughter on health. Although laughter yoga has increasingly been used in healthcare in recent years, positive outcomes have been reported across different age groups and health conditions. Laughter yoga performed with pregnant women has been reported to reduce the frequency of pregnancy-related symptoms and increase psychological well-being and prenatal attachment levels. However, no studies examining its effects on the outcomes addressed in the present study were identified in the literature. Therefore, this study aims to determine the effects of laughter yoga on perceived stress, psychosocial health, and brain fog among pregnant women in the third trimester. Keywords: laughter, pregnancy, stress, psychosocial health, brain fog

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 25, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

lLaughter,pregnancy,stress,psychosocial health,brain fog

Outcome Measures

Primary Outcomes (4)

  • Descriptive Information Form:

    This form was developed by the researchers based on the relevant literature to assess the sociodemographic characteristics of the participants.

    Baseline and immediately after completion of the final laughter yoga session

  • Perceived Stress Scale (PSS):

    The scale, developed by Cohen et al., consists of 14 items and was designed to assess the extent to which situations in an individual's life are perceived as stressful. Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very Often (4)." Seven positively worded items are reverse-scored. In the Turkish adaptation, reliability, and validity study of the Perceived Stress Scale conducted by Eskin et al., the Turkish PSS-14 demonstrated an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87. The scale was concluded to be a valid and reliable instrument for assessing perceived stress.

    Baseline and immediately after completion of the final laughter yoga session

  • The Antenatal Psychosocial Health Assessment Scale

    This scale was developed by Yıldız to assess psychosocial health during pregnancy. It consists of 46 items and six subscales: characteristics related to pregnancy and the spousal relationship, characteristics related to anxiety and stress, characteristics related to domestic violence, characteristics related to the need for psychosocial support, familial characteristics, and characteristics related to physical and psychosocial changes associated with pregnancy. The total score is divided by the number of items to obtain a mean score ranging from 1 to 5. Scores closer to 1 indicate greater psychosocial health problems during pregnancy, with a score of 1 representing very poor psychosocial health. The Cronbach's alpha coefficient of the scale was reported as 0.93.

    Baseline and immediately after completion of the final laughter yoga session

  • Brain Fog Scale

    The scale consists of 30 items and three subscales. The total score ranges from 30 to 150. The Cognitive Symptoms subscale is scored between 17 and 85, the Physical Symptoms subscale between 8 and 40, and the Psychological Symptoms subscale between 5 and 25. Higher scores on the subscales and/or the overall scale indicate higher levels of brain fog.

    Baseline and immediately after completion of the final laughter yoga session

Study Arms (2)

1.laughter

EXPERIMENTAL

laughter therapy

Other: laughter therapy

2 CONTROL

NO INTERVENTION

Interventions

Participants will receive a total of \*\*4-5 laughter therapy sessions\*\* during the study period.

1.laughter

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Having no communication barriers
  • Applying for antenatal education during the study period
  • Volunteering to participate in the study
  • Being in the third trimester of pregnancy
  • Having no condition that would prevent participation in laughter yoga sessions

You may not qualify if:

  • Refusing to participate in the study
  • Providing incomplete responses or failing to answer the questions in the questionnaire
  • Having a high-risk pregnancy
  • Having a multiple pregnancy (e.g., twins)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı İbrahim Çeçen University

Ağrı, Ağri, 04100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental Fatigue

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. prof

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 31, 2026

Study Start

November 30, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations