NCT07449013

Brief Summary

This research was designed as a randomized controlled experimental study to determine the effects of laughter yoga and emotional freedom techniques(EFT) on anxiety in pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jan 2025

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

February 27, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

AnxietyPregnancyLaughter YogaEmotional Freedom Technique

Outcome Measures

Primary Outcomes (3)

  • State-Trait Anxiety Inventory (STAI) scale

    This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.

    between six to twelve months

  • Introductory Information Form

    A form that includes questions about women's socio-demographic and pregnancy and characteristics.

    between six to twelve months

  • Pregnancy-related anxiety scale(PrAS)

    This scale was originally developed by Brunton, and its Turkish validity and reliability were established by Solt and Gul. It is used to evaluate pregnancy-related anxiety. Higher total scores, as well as higher scores across its nine subscales, indicate greater levels of anxiety in pregnant women.It will be used to assess pregnancy-related anxiety.

    between six to twelve months

Study Arms (3)

Laughter yoga group

EXPERIMENTAL

Laughter yoga will be applied to pregnant women with anxiety during pregnancy.

Other: Laughter yoga

Emotional freedom technique(EFT) group

EXPERIMENTAL

Emotional freedom technique will be applied to pregnant women with anxiety during pregnancy.

Other: Emotional freedom technique

Control group

NO INTERVENTION

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms.

Interventions

Pregnant women in the laughter yoga group will undergo a total of six sessions over two weeks, three times a week, with each session lasting an average of 40-50 minutes. The laughter yoga programme consists of the following: hand clapping and warm-up exercises, deep breathing exercises, childlike games, laughter exercises and laughter meditation.

Also known as: Laughter therapy
Laughter yoga group

Pregnant women in the emotional freedom technique group will undergo a total of six sessions over two weeks, three times a week, with each session lasting an average of 40-50 minutes.The emotional freedom technique application consists of the following sections: Identifying the Problem, Grading the Problem, Creating the Setup Phrase, Applying Tapping, Evaluating the Result.

Also known as: Emotional freedom techniques
Emotional freedom technique(EFT) group

Eligibility Criteria

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

You may qualify if:

  • For the laughter yoga group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga.
  • For the emotional freedom technique(EFT) group: Pregnant women who are willing to participate in the study, can read and understand Turkish, are aged 18 or over, have scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, have not previously undergone EFT, and have no infections, wounds, scars, etc. in the tapping areas where EFT will be applied.
  • For the control group: Pregnant women who volunteered to participate in the study, can read and understand Turkish, are aged 18 or over, scored 37 or above on the STAI, have a spontaneous pregnancy, are in their second or third trimester, and have not previously practised laughter yoga or EFT.

You may not qualify if:

  • For the laughter yoga group: Those wishing to continue working, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), those with psychiatric illnesses and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), those with any issues that prevent communication (such as impaired hearing, speech, or comprehension), those using pharmacological or non-pharmacological methods to reduce anxiety, those who have undergone abdominal surgery in the last three months, and pregnant women with glaucoma, hernia, epilepsy, bleeding haemorrhoids, or heart disease.
  • For the EFT and control group: Those who do not wish to continue the study, those diagnosed with a high-risk pregnancy, those with chronic illnesses (hypertension, diabetes, thyroid disorders, etc.), Those with psychiatric disorders and/or undergoing psychiatric treatment (pharmacotherapy or psychotherapy), Those with any condition that impedes communication (such as impaired hearing, speech, or comprehension), Pregnant women using either pharmacological or non-pharmacological methods to reduce anxiety.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli Healthy Life Center

Kırklareli, Centre, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Efsun Derin

    Kırklareli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

January 1, 2025

Primary Completion

March 15, 2026

Study Completion

May 12, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations