NCT07031648

Brief Summary

The aim of the study was to determine the effect of laughter yoga and pilates on pregnancy adjustment, anxiety and prenatal attachment in pregnant women who received childbirth preparation training.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
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

Study Progress88%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2026

Expected
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 13, 2025

Last Update Submit

June 20, 2025

Conditions

Keywords

pilatesLaughter YogaAnxietyPrenatal Attachment

Outcome Measures

Primary Outcomes (3)

  • Pregnancy-Related Anxiety Scale

    It is a 4-point Likert type scale consisting of a total of 33 questions. The scale consists of 9 sub-dimensions. In the scale, 11 items are reverse-coded, and the lowest score is 33 and the highest is 132 points.

    four week

  • Prenatal Self-Assessment Scale

    It is a 4-point Likert-type scale consisting of 79 items. A minimum of 79 and a maximum of 316 points can be obtained on the scale

    four week

  • Prenatal Attachment Inventory

    It consists of 21 items. Each item is of the quadruple Likert type, which can score between 1 and 4. A minimum of 21 and a maximum of 84 points can be obtained from the scale.

    four week

Study Arms (3)

Laughter Yoga Group

EXPERIMENTAL

Giving information about the yoga of meeting and laughter, Obtaining written consent through the informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school, Practicing laughter yoga 2 times a week for 4 weeks for a total of 8 sessions, Sessions should consist of a maximum of 15 people, A total of 45 minutes of laughter sessions for pregnant women, At the end of the fourth week, the final test will be administered

Other: Laughter Yoga Group

Pilates Group

EXPERIMENTAL

Providing information about meeting and Pilates, Obtaining written consent through the informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school, Performing a total of 8 sessions of pregnant pilates exercises for 4 weeks, 2 times a week, Sessions should consist of a maximum of 10 people, A total of 45 minutes of pilates exercise for pregnant women, At the end of the fourth week, the final test will be administered

Other: Pilates Group

Education Group

OTHER

Providing information about the research, Obtaining written consent through the informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school (pregnancy, postpartum care, baby care, breastfeeding, etc.) At the end of the fourth week, the final test will be administered

Other: Education Group

Interventions

iving information about the yoga of meeting and laughter, Obtaining written consent through the informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school, P

Laughter Yoga Group

Providing information about meetings and Pilates, Obtaining written consent through an informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school, Doing a total of 8 sessions of pregnant pilates exercises for 4 weeks, 2 times a week, Sessions should consist of a maximum of 10 people, A total of 45 minutes of pilates exercise for pregnant women, At the end of the fourth week, the final test will be administered

Pilates Group

Providing information about the research, Obtaining written consent through the informed consent form, Pre-test will be applied in the first week Providing routine pregnancy school trainings by midwife trainers in the pregnancy school (pregnancy, postpartum care, baby care, breastfeeding, etc.) At the end of the fourth week, the final test will be administered

Education Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Week of pregnancy over 20 weeks Without multiple and risky pregnancies, Those who have not undergone intra-abdominal surgery, Not having a mental illness, No physical disability, Without any fetal anomalies and intrauterine growth retardation, Pregnant women who agreed to participate in the study were included in the study.

You may not qualify if:

  • Incomplete filling of data forms, Not volunteering to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet Güney

Kastamonu, 37100, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Aktan B, Kayikcioglu F, Akbayrak T. The comparison of the effects of clinical Pilates exercises with and without childbirth training on pregnancy and birth results. Int J Clin Pract. 2021 Oct;75(10):e14516. doi: 10.1111/ijcp.14516. Epub 2021 Jul 5.

    PMID: 34117824BACKGROUND
  • Baghdari N, Sadeghi Sahebzad E, Kheirkhah M, Azmoude E. The Effects of Pregnancy-Adaptation Training on Maternal-Fetal Attachment and Adaptation in Pregnant Women With a History of Baby Loss. Nurs Midwifery Stud. 2016 May 21;5(2):e28949. doi: 10.17795/nmsjournal28949. eCollection 2016 Jun.

    PMID: 27556052BACKGROUND
  • Ghandali NY, Iravani M, Habibi A, Cheraghian B. The effectiveness of a Pilates exercise program during pregnancy on childbirth outcomes: a randomised controlled clinical trial. BMC Pregnancy Childbirth. 2021 Jul 2;21(1):480. doi: 10.1186/s12884-021-03922-2.

    PMID: 34215198BACKGROUND
  • Mazzarino M, Kerr D, Morris ME. Pilates program design and health benefits for pregnant women: A practitioners' survey. J Bodyw Mov Ther. 2018 Apr;22(2):411-417. doi: 10.1016/j.jbmt.2017.05.015. Epub 2017 May 31.

    PMID: 29861243BACKGROUND
  • Rockliffe L, Peters S, Heazell AEP, Smith DM. Factors influencing health behaviour change during pregnancy: a systematic review and meta-synthesis. Health Psychol Rev. 2021 Dec;15(4):613-632. doi: 10.1080/17437199.2021.1938632. Epub 2021 Jun 29.

    PMID: 34092185BACKGROUND
  • Agapinar Sahin S, Bekar M. The influence of laughter yoga on pregnancy symptoms, mental well-being, and prenatal attachment: A randomized controlled study. Health Care Women Int. 2023 Jun;44(6):782-801. doi: 10.1080/07399332.2022.2164284. Epub 2023 Jan 10.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Demet Güney, MSc.

    https://kastamonueah.saglik.gov.tr/

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Type of Study: It is a randomized controlled experimental study and is planned based on the pre-test-post-test model Pregnant women randomly assigned to the Laughter Yoga and Pilates Group constitute the experimental group of the study. Only those who received planned training for pregnancy and postpartum constituted the control group of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc., Research Assist

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 22, 2025

Study Start

June 13, 2025

Primary Completion

September 20, 2025

Study Completion (Estimated)

June 20, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations