The Effect of Guided Imagery and Diaphragmatic Breathing Exercise in Pregnant Women With Hyperemesis Gravidarum
1 other identifier
interventional
180
0 countries
N/A
Brief Summary
Objective: The aim of the researchers is to determine the effects of guided imagery and diaphragmatic breathing exercise application on nausea, vomiting severity, and anxiety level in pregnant with hyperemesis gravidarum. Methods: This study was planned as a single-blind randomized controlled experimental study. It is planned to be conducted with 180 pregnant women to be randomized in a university hospital in Southeastern Anatolia between April 2023 and August 2023. Data will be collected using the "Descriptive Information Form", "Nausea-Vomiting Severity Assessment Test During Pregnancy" and "Pregnancy-Related Anxiety Scale-R2". Keywords: Anxiety, Hyperemesis Gravidarum, Nausea-Vomiting, Guided Imagery, Diaphragmatic Breathing Exercise, Nursing,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 25, 2023
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2023
CompletedApril 25, 2023
April 1, 2023
3 months
November 28, 2022
April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nausea-Vomiting Severity
Nausea-Vomiting Severity Evaluation
20 minutes after interventions
Secondary Outcomes (1)
Pregnancy-Related Anxiety
20 minutes after interventions
Study Arms (3)
Breathing Exercise Group
EXPERIMENTALA total of 1 times day diaphragmatic breathing exercise will be made on 3 consecutive days (5 minutes diaphragmatic breathing exercise, 5 minutes relaxation exercise). Diaphragmatic breathing exercises will be performed at least 4 hours after the use of antiemetic drugs in the service. 20 minutes from the diaphragmatic breathing exercise application. Afterward, post-test data will be obtained using the Nausea-Vomiting Severity Evaluation Test During Pregnancy and Pregnancy-Related Anxiety scales. A total of 6 measurements will be made using the scales on the 1st, 2nd, and 3rd days.
Guided Imagery Group
EXPERIMENTAL10 minutes once a day for pregnant women with hyperemesis gravidarum who meet the research criteria the guided imagery compact disc will be played with the computer. A guided imagery compact disc will be watched at least 4 hours after the use of antiemetic drugs in the service.10 minutes once a day for pregnant women with hyperemesis gravidarum who meet the research criteria the guided imagery compact disc will be played with the computer. A guided imagery compact disc will be watched at least 4 hours after the use of antiemetic drugs in the service. Afterward, 20 minutes from the application post-test data will be obtained by using the Nausea-Vomiting Severity Assessment Test in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales. A total of 6 measurements will be made using the scales on the 1st, 2nd, and 3rd days.
Control Group
NO INTERVENTIONNo intervention will be made to the pregnant women in the control group, other than their routine daily care. Pre-test data will be obtained by applying the Nausea-Vomiting Severity Evaluation Test During Pregnancy and Pregnancy-Related Anxiety scales at least 4 hours after the use of antiemetic drugs in the service. 20 min from the pre-test data. Afterward, the final test data will be obtained by applying the Nausea-Vomiting Severity Evaluation Test During Pregnancy and Pregnancy-Related Anxiety scales. A total of 6 measurements will be made using the scales on the 1st, 2nd, and 3rd days.
Interventions
A total of 1 times day diaphragmatic breathing exercise will be made on 3 consecutive days (5 minutes diaphragmatic breathing exercise, 5 minutes relaxation exercise). Diaphragmatic breathing exercises will be performed at least 4 hours after the use of antiemetic drugs in the service. 20 minutes from the diaphragmatic breathing exercise application. Afterward, post-test data will be obtained using the Nausea-Vomiting Severity Evaluation Test During Pregnancy and Pregnancy-Related Anxiety scales. A total of 6 measurements will be made using the scales on the 1st, 2nd, and 3rd days.
10 minutes once a day for pregnant women with hyperemesis gravidarum who meet the research criteria the guided imagery compact disc will be played with the computer. A guided imagery compact disc will be watched at least 4 hours after the use of antiemetic drugs in the service.10 minutes once a day for pregnant women with hyperemesis gravidarum who meet the research criteria the guided imagery compact disc will be played with the computer. A guided imagery compact disc will be watched at least 4 hours after the use of antiemetic drugs in the service. Afterward, 20 minutes from the application post-test data will be obtained by using the Nausea-Vomiting Severity Assessment Test in Pregnancy and Pregnancy-Related Anxiety Scale-R2 scales. A total of 6 measurements will be made using the scales on the 1st, 2nd, and 3rd days.
Eligibility Criteria
You may qualify if:
- years and over,
- Being primiparous,
- Able to communicate verbally,
- Agreeing to participate in the study,
- Able to read and write,
- th week of pregnancy and above
- At least 3 days of hospitalization,
- Having a single and live fetus,
- No fetal congenital malformation,
- Pregnant women who do not have systemic diseases (GIS, audiovestibular, endocrine, infection, and psychological) that may cause nausea and vomiting other than nausea and vomiting caused by pregnancy will be included in the study.
You may not qualify if:
- Having a risky pregnancy diagnosis;
- Obstetric complications,
- Having a psychiatric diagnosis,
- With systemic disease,
- Having multiple pregnancies,
- Fetal congenital malformation,
- Pregnant women with systemic diseases that may cause nausea-vomiting will not be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Karacan E, Karacan E. Effects of guided imagery, and breathing exercise device on nausea-vomiting, and anxiety in hyperemesis gravidarum. J Reprod Infant Psychol. 2026 Jan 13:1-26. doi: 10.1080/02646838.2026.2615083. Online ahead of print.
PMID: 41531003DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
EMİNE KARACAN, PhD
ISKENDERUN TECHNICAL UNIVERSITY
Central Study Contacts
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
Study Record Dates
First Submitted
November 28, 2022
First Posted
April 25, 2023
Study Start
April 30, 2023
Primary Completion
July 30, 2023
Study Completion
August 15, 2023
Last Updated
April 25, 2023
Record last verified: 2023-04