The Effect of Diaphragmatic Breathing Exercises on Fetal Anxiety and Coping With Prenatal Stress
1 other identifier
interventional
108
1 country
1
Brief Summary
Objective: This study was conducted to determine the effect of diaphragmatic breathing exercises on coping with fetal anxiety and prenatal stress during pregnancy. Methods: This randomized controlled study was carried out at a family health center in eastern Turkey. The study sample consisted of 106 pregnant women (experimental group, 54; control group, 54). Those in the experimental group received diaphragmatic breathing exercises five times in two weeks, one time via face-to-face session and 4 times twice a week via video call. Those in the control group received no intervention. Data were collected using the Revised-Prenatal Coping Inventory (NuPCI) and the Fetal Health Anxiety Inventory (FHAI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedFirst Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 20, 2023
CompletedJuly 20, 2023
July 1, 2023
6 months
July 6, 2023
July 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Revised-Prenatal Coping Inventory (NuPCI)
The scale measures pregnant women's coping styles and perceptions of stress. It consists of 30 items and three subscales: Planning-preparation, Avoidance, and Spiritual-positive. This is a 5-point Likert-type scale, scoring from 0 (never) to 4 (very often). Higher planning-preparation and spiritual-positive subscale scores and lower avoidance subscale scores indicates higher coping with stress.
Change from Revised-Prenatal Coping Inventory at 2 weeks
Secondary Outcomes (1)
Fetal Health Anxiety Inventory (FHAI)
Change from Fetal Health Anxiety Inventory at 2 weeks
Study Arms (2)
Diaphragmatic breathing exercise
EXPERIMENTALDiaphragmatic breathing exercise training was given individually to each pregnant women in the experimental group by one of the trained researchers. Two weeks after the first application, the researcher made the pregnant woman repeat the application 2 days a week via video call. Thus, a total of five diaphragmatic breathing exercises were applied to pregnant women in the experimental group during two weeks. They continued to do breathing exercises for 20-30 minutes a day for ten minutes each day for two weeks as they could tolerate.
Control
NO INTERVENTIONThe researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms(Personal Information Form,Revised-Prenatal Coping Inventory (NuPCI), Fetal Health Anxiety Inventory (FHAI)) were re-administered 2 weeks later to women who did not receive any intervention.
Interventions
Diaphragmatic breathing exercise training was given individually to each pregnant women in the experimental group by one of the trained researchers. Two weeks after the first application, the researcher made the pregnant woman repeat the application 2 days a week via video call. Thus, a total of five diaphragmatic breathing exercises were applied to pregnant women in the experimental group during two weeks. They continued to do breathing exercises for 20-30 minutes a day for ten minutes each day for two weeks as they could tolerate.
Eligibility Criteria
You may qualify if:
- being pregnant women in their second and third trimesters (between 28-36 weeks);
- being ≥18 years old;
- having no medical pregnancy complications;
- having no diagnosed mental illness;
- having no fetal anomaly diagnosis;
- using a smartphone.
You may not qualify if:
- Diagnosis of any chronic disease and initiation of medication for chronic disease during the research process
- Detection of fetal congenital malformation in the research process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Fırat University
Elâzığ, Province, 23119, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This study was designed as a randomized controlled trial
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assitant Professor
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 20, 2023
Study Start
September 7, 2022
Primary Completion
March 1, 2023
Study Completion
April 30, 2023
Last Updated
July 20, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share