NCT05780112

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

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 5, 2022

Last Update Submit

March 9, 2023

Conditions

Keywords

Breathing ExerciseNausea and VomitingNursingPregnancyQuality of Life

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

EXPERIMENTAL

The 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.

Other: breathing exercise

control group

NO INTERVENTION

At 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.

Experimental group

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

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

Locations