The Effectiveness of The Breathing Exercise On The Nausea, Vomiting And Breathing Exercise In Pregnancy
Evaluation of The Effectiveness of The Breathing Exercise On The Nausea, Vomiting And Quality of Life In The Early Pregnancy Period: A Single-Blind Randomized Controlled Trial
1 other identifier
interventional
104
1 country
1
Brief Summary
Aim: This study aimed to investigate the effectiveness of the breathing exercise on pregnancy-related nausea and vomiting and the quality of life in the early pregnancy period. Background: Nausea and vomiting during pregnancy is a condition that can negatively affect the quality of life and the course of pregnancy in pregnant women. Nausea and vomiting during pregnancy with breathing exercises and can positively affect the quality of life women. Methods: This study is a single-blind randomised controlled trial. The sample consisted of 104 pregnant women. The Personal Information Form, the Nausea and Vomiting in Pregnancy Instrument and the 36-Item Short-Form Health Survey were used to collected the data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pregnancy
Started Jun 2019
Shorter than P25 for not_applicable pregnancy
1 active site
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 Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedMarch 22, 2023
March 1, 2023
11 months
January 5, 2022
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nausea and Vomiting in Pregnancy Instrument (NVPI)
The Nausea and Vomiting in Pregnancy Instrument was developed by Swallow et al. (2002) for evaluating nausea and vomiting during pregnancy 'within the last week'. The NVPI was used after the time frame was re-configured as 'the week in which the pregnant woman had nausea and vomiting most frequently'. The NVPI is comprised of three questions that addressed the frequency of nausea, retching, and vomiting for one week. Each question was scored on the basis of a 6-point Likert scale. The scores to be obtained from each NVPI question ranged from 0 to 5 points, and the minimum and maximum scores to be obtained from the NVPI were respectively 0 and 15 points. There is no cut-off point for the NVPI. The increase in the NVPI scores demonstrates that the severity of nausea and vomiting rose
Change from Nausea and Vomiting in Pregnancy Instrument at 4 weeks
36-Item Short-Form Health Survey
SF-36 is composed of 36 questions and eight sub-scales (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health). ). Just as the SF-36 and its eight sub-scales are evaluated separately, the SF-36 can also be evaluated under two main dimensions, namely, physical dimension and mental dimension. The physical dimension covers the domains of physical functioning, role physical, bodily pain, general health perceptions, and vitality while the mental dimension includes the domains of social functioning, role emotional, mental health, general health perceptions, and vitality. For the physical and mental dimensions, the mid-range value was set as 50 points, and the scores above and below 50 points are successively categorized as being above and below the mid-range.
Change from 36-Item Short-Form Health Survey Instrument at 4 weeks
Study Arms (2)
Experimental group
EXPERIMENTALThe pregnant women did the breathing exercise in accordance with the 'Practical Guideline on Breathing Exercise for Reducing Nausea and Vomiting in the Pregnant Women'. The breathing exercise training took on average 15-20 minutes for each pregnant woman. After the training, the pregnant women were asked to do the breathing exercise properly and effectively in accordance with the guideline for a minimum of five minutes at least twice a day for four weeks. * Refresher training was given to the pregnant women through phone calls at the end of the first and third weeks and home visits at the end of the second week, and in each of these interviews, the pregnant women's breathing exercise practices were followed and the NVPI was applied to the pregnant women. * At the end of the research, in other words, at the end of the fourth week, the NVPI and SF-36 were applied once again to the pregnant women in the maternity polyclinic, and hence, the follow-up process came to an end.
control group
NO INTERVENTIONAt the beginning of the research (pretest phase), without giving information about the breathing exercise practice to the pregnant women and making them practice the exercise, the researcher only asked pregnant women in the control group to fill in the Personal Information Form and applied the NVPI and SF-36 to the pregnant women. * The pregnant women were called by phone at the end of the first and third weeks and their homes were visited at the end of the second week, and in each interview, information about their health status was received from them and the NVPI was applied to them. * At the end of the research (post-test phase), in other words, at the end of the fourth week, the NVPI and SF-36 were applied once again to the pregnant women in the maternity polyclinic.
Interventions
* Place one hand on your chest and the other on your stomach. * Slowly take a deep breath through the nose. * During inhalation, your hand on your stomach should rise upwards as the air fills the lungs. If it is under your hand on the chest, there should not be much movement. * Hold your breath and stretch your muscles in a second or two. * Take air through your nose with your mouth closed and exhale slowly through your mouth by pursing your lips like a whistle. * Set the time you use when exhaling air to be twice the time you use when exhaling. * As you exhale, focus on the inward movement of your abdominal hand.
Eligibility Criteria
You may qualify if:
- Having the ability to communicate,
- Being aged 15-49 years,
- Being in the 12th or an earlier week of pregnancy with a living fetus,
- Not having fetal congenital malformation,
- Not having systemic diseases (gastrointestinal system, audiovestibular, endocrine, infection, and psychological diseases) which are likely to lead to nausea and vomiting other than pregnancy-related nausea and vomiting,
- never using a medication against nausea and vomiting before.
You may not qualify if:
- Having a multiple pregnancy,
- Having fetal congenital malformation,
- Having systemic diseases that are likely to lead to nausea and vomiting,
- Using medication against nausea and vomiting,
- Having the risk of miscarriage,
- Having speech disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Inonu University
Malatya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Women's Health and Diseases Nurse
Study Record Dates
First Submitted
January 5, 2022
First Posted
March 22, 2023
Study Start
June 1, 2019
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
March 22, 2023
Record last verified: 2023-03