NCT05954754

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

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

July 6, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

Pregnancy,breathing exercises,fetal anxiety,stress,coping

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

EXPERIMENTAL

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.

Other: Diaphragmatic Breathing Exercises

Control

NO INTERVENTION

The 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.

Diaphragmatic breathing exercise

Eligibility Criteria

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

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

Study Sites (1)

Fırat University

Elâzığ, Province, 23119, Turkey (Türkiye)

Location

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
Model Details: This study was designed as a randomized controlled trial
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

Locations