Viewing Study NCT06520930



Ignite Creation Date: 2024-10-25 @ 7:56 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06520930
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-20

Brief Title: The Effect of Breathing Exercises on Comfort Level in Primiparous Pregnant Women
Sponsor: None
Organization: None

Study Overview

Official Title: The Effect of the Structured Supportive Approach Based on Kolcaba Comfort Theory Applied to Primiparous Pregnant Women on the Comfort Level in the Last Trimester
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: breathing
Brief Summary: Pregnancy is a special period in which some changes occur in bio-psycho-social areas and adaptation to these changes is achieved Üzar and Erkan 2019 While this special period creates happiness and peace in some women it can cause emotional and relational changes in some women create anxiety and anxiety and negatively affect their comfort level Al-Mutawtah et al 2023 Yar and Yılmaz 2021 In order to reduce the effects of complaints experienced during pregnancy and ensure adaptation nurses who provide holistic innovative effective and supportive care determine the comfort needs of the individual and the family and improve their comfort levels by planning and applying interventions specific to the areas needed

It increases Arslankılıç and Göl 2020 Kolcaba1991 In this context breathing exercises which are defined as an invisible spirit that provides the connection between body mind and soul gives life to its owner has an important place in order to increase the comfort level and ensure adaptation to the pregnancy process Kartal 2018 Because breathing exercises stimulate the parasympathetic nervous system increase blood oxygenation and as a result trigger the secretion of endorphins The increased release of endorphins reduces the heart rate resulting in a feeling of calm In addition endorphin suppresses the sympathetic nervous system and reduces the release of cortisol the stress hormone thus keeping psychotic emotions under control Issac et al 2023Thus the complaints that occur during pregnancy can be minimized with correct and effective breathing techniques and the comfort level can be increased As a result of literature reviews Regular breathing exercises increase lung volume increase the endurance and efficiency of the diaphragm muscle reduce dyspnea provide easier breathing and help eliminate bronchial secretions Özulus 2018 Tucker and Jenkins 1996 It has been found that it is effective in reducing hypertension fatigue and anxiety and that a 30-session intervention lasting 5 minutes per day for women who have given birth prematurely significantly reduces anxiety Ölçer and Oskay 2015 Chang et al 2009 For this reason the concept of comfort should be evaluated multidimensionally during pregnancy and holistic nursing interventions should be implemented to increase the comfort level

In this study it is envisaged that breathing exercise practices will increase the general comfort level of primiparous women such as adaptation to pregnancy increase in sleep quality decrease in pain decrease in anxiety levels improvement in vital signs and conscious management of third trimester changes At the same time these research findings will constitute an important data source in research on the general comfort level effectiveness of breathing exercises to be performed on primiparous pregnant women from the 2nd trimester onwards in the 3rd trimester Because no randomized controlled study has been conducted in Turkey regarding the effect of breathing exercise on the general comfort level of last trimester pregnant women
Detailed Description: The population of the research consists of primiparous women who applied to the Private Metrolife Hospital Obstetrics and Gynecology outpatient clinic The sample size of the study was determined using post hoc power analysis G-Power 3194 program In the power analysis conducted for the research it was determined that a total of 72 primiparous women including at least 36 people in both groups were included in the study in order to reach a 95 confidence interval an effect size of 06 an α-type error estimate of 005 and 80 power in the experimental and control groups with the pretest-posttest It was determined that there was a need for inclusion In view of the possibility that primiparous pregnant women who will participate in the study may withdraw from the study for various reasons the total number of primiparous pregnant women was determined as 80 40 for the control group and 40 for the experimental group The research was completed with 40 primiparous pregnant women in the intervention group and 40 primiparous pregnant women in the control group according to the CONSORT flow chart

The breathing exercises to be applied were taught face to face to each pregnant woman by the researcher who has a amp34Breathing Therapyamp34 certificate The taught practice was then repeated by the pregnant woman and the researcher together In the next step pregnant women were asked to perform the application themselves In this way it was determined whether individual breathing exercise practices were performed correctly and effectively After the one-on-one training was completed the pregnant women were divided into groups of maximum six people and breathing exercise exercises were performed 7 days a week once a day and once a week face-to-face for 8 weeks Breathing exercises were administered face to face to a maximum of two groups per day and each session lasted approximately 45 minutes In addition for 8 weeks a short reminder message was sent to pregnant women every morning between 1000-1100 to prevent them from disrupting their daily breathing exercise practices and they were called in the evening between 1700-1800 to check whether they had performed the application correctly or not It was checked whether they were experiencing any problems

Data collection tools Introductory Information Form This form was prepared by the researcher by scanning the relevant literature Socio-demographic characteristics of primiparous pregnant women age age at marriage duration of marriage education level profession income level social security status place of residence family structure obstetric characteristics gestational age planned pregnancy problems experienced during pregnancy any relaxing practice and pulse respiratory rate and saturation values were checked

General Comfort Scale GAS was used The intervention group had data collection tools filled out before and after therapy

Statistical significance level will be accepted as plt005

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None