NCT07360184

Brief Summary

Primiparous women constitute a special risk group who may experience higher levels of fear of childbirth and lower birth self-efficacy during pregnancy due to their lack of prior childbirth experience. Fear of childbirth is associated with increased anxiety, negative birth experiences, and unnecessary medical interventions, while birth self-efficacy is an important determinant of adaptation to the birth process and positive birth outcomes. In recent years, non-pharmacological and mind-body-based interventions have become increasingly important in the management of these psychological problems. Laughter yoga is a complementary method that combines conscious laughter exercises with breathing techniques to reduce stress and anxiety. This randomized controlled trial aims to evaluate the effect of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women. The study aims to provide scientific evidence for the use of laughter yoga as an effective, safe, and inexpensive psychosocial intervention that can be applied in prenatal care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

28 days

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Wijma Childbirth Expectation/Experience Questionnaire - Version A (W-DEQ/ Version A)

    It was developed by Klaas and Barbro Wijma to measure women's fear of childbirth. The scale consists of 33 items. Responses on the scale are numbered from 0 to 5 and are on a six-point Likert scale. 0 means "completely," and 5 means "not at all." The minimum score on the scale is 0, while the maximum score is 165. As the score increases, so does the fear of childbirth experienced by women. While the first version of the scale did not specify a score range, subsequent studies determined a scoring range. This range can be used when interpreting scale scores. The total item score is interpreted as 0-60 for low fear of childbirth, 61-84 for moderate fear of childbirth, and 85 and above for high fear of childbirth.

    Baseline (Day 0) and Week 4

Secondary Outcomes (1)

  • Self-Efficacy Scale in Childbirth (SEB-C32)

    Baseline (Day 0) and Week 4

Study Arms (2)

Laughter

EXPERIMENTAL

group performing laughter yoga

Behavioral: Laughter yoga

Control

NO INTERVENTION

group not receiving intervention

Interventions

Laughter yogaBEHAVIORAL

Sessions will consist of warm-up and breathing exercises, guided intentional laughter exercises, diaphragmatic breathing and relaxation, followed by a short mindfulness and closing phase.

Laughter

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being 18 years of age or older,
  • never having given birth before
  • be a primiparous pregnant woman experiencing her first birth,
  • be pregnant with a single baby,
  • be approximately 28-34 weeks pregnant at the start of the intervention,
  • be planning a vaginal birth,
  • have the ability to read and speak Turkish,
  • volunteer to participate in the study

You may not qualify if:

  • A diagnosis of high-risk pregnancy or the presence of serious obstetric complications that prevent participation in exercise (e.g., placenta previa, uncontrolled gestational hypertension or preeclampsia, bed rest recommended due to threatened preterm labor, cervical insufficiency),
  • multiple pregnancy,
  • history of recurrent pregnancy loss (≥2 miscarriages) or pregnancy achieved through assisted reproductive techniques (e.g., IVF),
  • diagnosis of a known psychiatric disorder (major depression, anxiety disorder, psychosis, etc.),
  • history of alcohol or substance use during pregnancy,
  • Severe orthopedic problems or chronic respiratory system diseases that prevent participation in light exercise or laughter exercises,
  • Participation in other structured prenatal interventions (e.g., prenatal yoga, hypno-birth, intensive childbirth education programs) aimed at reducing fear or anxiety about childbirth during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdağmadeni School of Health

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

February 15, 2026

Primary Completion

March 15, 2026

Study Completion

March 22, 2026

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations