The Effects of Breathing Exercises and Virtual Reality Applications During Pregnancy and Labor.

NCT05527236 | Completed DMC

• 1 other identifier: Virtual Breathing
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Aim and Objectives: The purpose of this study was to determine the effects of breathing exercises and virtual reality applications during pregnancy and labor on labor pain, duration, and birth satisfaction. Background: Conducted studies show that practices such as virtual reality have positive effects on labor. However, there is no study that compares the effects of breathing exercises with virtual reality applications on labor. Design: A randomized controlled experiment was conducted by the CONSORT guidelines. Methods: The study included 114 pregnant women (Breathing Exercise Group:39, Virtual Reality Group:37, Control Group:38). The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercises again. The virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.

Conditions

Labor Pain; Labor Onset; Patient Satisfaction; Virtual Reality; Breathing; Tic

Keywords

breathing exercises; virtual reality; pain intensity; duration of labor; birth satisfaction

Outcome Measures

Primary Outcomes (1)

• ''Labor pain''

  Labor pain was evaluated with the Visual Analogue Scale (VAS).

  ''1 minute later''

Secondary Outcomes (2)

• ''Duration of labor''

  ''within the first 10 hours''

• ''Birth satisfaction''

  ''within the first 4 hours''

Study Arms (3)

Breathing Exercise Group

EXPERIMENTAL

The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercise again. As soon as the virtual reality glasses and breathing exercise device were removed, VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation section of the labor observation form was filled out. Satisfaction with birth was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.

Other: Breathing Exercise

Virtual Reality Group

EXPERIMENTAL

The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.

Other: Virtual Reality

Control Group

NO INTERVENTION

Descriptive information form was filled out at 36th week of pregnancy in a quiet pregnant outpatient clinic in the hospital. After participants were admitted to the delivery room of Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital at the 40th week of pregnancy, and taken to their beds, in labour observation form, the labour section and the birth evaluation section which is used to evaluate the second and third stages of labour were filled out. Then, VAS was applied when cervical dilatation was 4 cm (the beginning of the active phase). Birth satisfaction was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed. No application was made to pregnant women in this group, except for routine practices in the pregnant outpatient clinic at the hospital and in the delivery room.

Interventions

Breathing Exercise OTHER

The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm), the breathing exercise group was made breathing exercises again. As soon as the virtual reality glasses and breathing exercise device were removed, VAS was applied. In order to evaluate the second and third stages of labor, the birth evaluation section of the labor observation form was filled out. Satisfaction with birth was evaluated with the ''Birth Satisfaction Scale'' within the first 4 hours after birth after the delivery was completed.

Breathing Exercise Group

Virtual Reality OTHER

The research was carried out in two stages. In the first stage, for the experimental groups at the 36th-39th weeks of pregnancy, a 10-minute breathing exercise was performed 3 times a week using virtual reality glasses and a breathing exercise device. In the second stage of the study (when the cervical dilatation was 4 cm) the virtual reality group watched a 10-minute video with virtual reality glasses. Once the virtual reality glasses were removed from experimental groups Visual Analogue Scale was applied. Birth satisfaction was evaluated with the Birth Satisfaction Scale within the first 4 hours after the delivery was completed.

Virtual Reality Group

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In the 36th week of pregnancy,
• Those who gave birth at 40 weeks of gestation,
• Those who will have a normal (vaginal) birth,
• Primiparas,
• years old and over,
• Able to communicate verbally,
• Who agreed to participate in the study,
• Those who can read and write,
• Those who have COVID-19 test negative, no contact or doubt.

You may not qualify if:

• Have no risks regarding the pregnant woman and fetus,
• Multiparous,
• Those who underwent cesarean section,
• Having visual or auditory impairment,
• Having any infection in the mouth,
• Having any contagious eye disease,
• Those administered analgesics during labour,
• Those who have COVID-19 test positive, contact or doubt.

Sponsors & Collaborators

• Semra Çevik, phD: lead

Study Sites (1)

Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Patient Satisfaction; Respiratory Aspiration; Tics; Pain

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Dyskinesias; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 2, 2022
• Study Start: October 15, 2020
• Primary Completion: January 15, 2022
• Study Completion: May 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)