- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265935
Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes
The Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes
Study Overview
Status
Intervention / Treatment
Detailed Description
It will be carried out as a randomized controlled experimental design to determine the fatigue and quality of life of pregnant women with gestational diabetes.
Material and method of the research:
Type of Study: This research is a randomized controlled study.
Research Questions/Hypotheses:
Hypothesis 0 (H0): Diaphragmatic breathing exercise has no effect on fatigue and quality of life in pregnant women with gestational diabetes.
Hypothesis 1 (H1): Diaphragmatic breathing exercise has an effect on fatigue and quality of life in pregnant women with gestational diabetes.
Location and Characteristics of the Research: The research will be conducted with pregnant women with gestational diabetes who applied to the gynecology outpatient clinic of Şanlıurfa Training and Research Hospital between 1 August 2023 and 1 August 2024 and who meet the inclusion criteria. This hospital was chosen due to its nature as a regional hospital and its density of pregnant women.
Population-sample of the research: The population of this research will consist of pregnant women with gestational diabetes who were followed in the gynecology outpatient clinic of Şanlıurfa Training and Research Hospital between 1 August 2023 and 1 August 2024. The sample size was calculated as 60 pregnant women by performing GPower analysis, taking into account the tests to be used to calculate the minimum sample size to be included in the study. The sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women diagnosed with gestational diabetes, who meet the inclusion criteria for the study, who agree to participate in the study, who are subjected to diaphragmatic breathing exercise, and 30 pregnant women diagnosed with gestational diabetes, who are not applied diaphragmatic breathing exercise.
Data Collection Forms and Tools Pregnancy Identification Form: This form was prepared and developed by researchers based on the literature. It consists of questions aimed at determining the sociodemographic, medical and obstetric characteristics of pregnant women with gestational diabetes.
SF-36 Quality of Life Scale: SF-36 Quality of Life Scale is a self-assessment scale consisting of 36 questions and eight subscales, developed by Ware in 1987 to measure care outcomes in general, not specific to age, disease or treatment, and to examine health-related quality of life. . The second question of the scale includes the perception of change in health in the last 12 months, and the other questions are evaluated considering the last four weeks. The Physical and Mental Health Summary Score is obtained by weighting the scores of the questions containing the subscales of the SF-36 Quality of Life Scale. Total score calculation is not possible. The resulting summary scores and subscale scores are expressed as continuous variables ranging from 0 to 100. Zero indicates bad health, 100 indicates well-being. The scale has no cut-off point. The validity and reliability of the scale in Turkey was conducted by Pınar in 1995 on 50 cardiology, 50 hemodialysis and 80 diabetes mellitus patients. According to this; Regardless of patient groups, the test-retest reliability coefficient of the scale was found to be 0.94, and the Crohnbach's Alpha value, which indicates internal consistency, was 0.92 .
Visual Similarity Scale for Fatigue: It was developed by Lee et al. in 1990 to measure the level of fatigue in various populations, including healthy adults and those with chronic diseases. The validity and reliability study of the scale for our country was conducted by Yurtsever and Bedük in 2003. YİGBS consists of 18 items. Of these items, 13 items measure Fatigue and five items measure Energy sublevel. Each item of the scale has a 10 cm horizontal line with positive statements at one end and negative statements at the other end. People who fill out this scale are asked to mark the point that best reflects the emotion they feel when reading the statements on the scale. Then, the intersection point at the marked location is measured with a ruler separately for each question, and the measured length is determined as the score of that item and evaluated objectively. The highest score that can be obtained from the fatigue subscale is 130 and the lowest score is 0. The highest score that can be obtained from the energy subscale is 50 and the lowest score is 0. A high score from the Fatigue subscale and a low score from the Energy subscale indicate that the severity of fatigue is high.[2] Cronbach's Alpha internal consistency coefficient for the 13-item fatigue subscale of the scale was found to be 0.90, and for the five-item energy subscale was 0.74.
Diaphragmatic Breathing Exercise: In diaphragmatic breathing exercise; Individuals lie on their back with their legs flexed, a pillow under their head, and place their dominant hand on their abdomen and the other hand on their chest. While breathing slowly through the nose, they need to pay attention to the hand in the abdominal area and reduce the rib cage movement by increasing the abdominal movement. During inspiration, as air fills the lungs, the hand on the abdomen should rise up and the hand on the chest should not move too much. It makes participants feel relaxed and relaxed with breathing exercise.
Collection of Data Data will be obtained from pregnant women with gestational diabetes who apply to the gynecology clinic of Şanlıurfa Training and Research Hospital and meet the sample selection criteria. Before the application, an explanation will be given to the pregnant women about the purpose of the research, and if they volunteer, their verbal and written consent will be obtained through the "Informed Volunteer Consent Form". Information about pregnant women will be collected by the researcher.
Application of Research Pregnant women will be informed about the research and written and verbal permissions will be obtained.
Information about pregnant women will be recorded. Pregnant women with gestational diabetes, whose diagnosis of gestational diabetes has been decided by the physician and who have given consent to participate in the study, will be assigned to 2 groups by randomization method: experimental (diaphragmatic breathing exercise group) and control (diaphragmatic breathing exercise group).
The first evaluations of pregnant women in both groups will be carried out between 10:00-12:00, and the Pregnancy Identification Form, Visual Similarity Scale for Fatigue and SF-36 Quality of Life Scale will be applied to the pregnant women before the training.
Experimental Group: Breathing exercise will be explained to the pregnant woman in a way she can understand, will be taught and will be applied for 5 minutes. When doing the diaphragmatic breathing exercise, participants will be told to take one chest breath after 4-5 diaphragmatic breaths to avoid hyperventilation. The pregnant woman will be advised to close her eyes during exercise and concentrate on breathing and focus her attention in this direction. If there is tremors, sweating, restlessness, palpitations, numbness in the hands or lips, or uterine contraction, participants will be told to stop the exercise and rest for a few minutes. Pregnant women will be given a phone number they can reach at any time during the one-month program. Feedback will be received, questions will be answered, a training brochure will be given and the program will be completed.
During their follow-up two weeks later, pregnant women will be asked to bring the survey form with them. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be completed again. How he did the exercise, whether he felt any effects, and his satisfaction will be questioned. Their questions will be answered. Participants will be informed that participants need to come for a re-check in two weeks.
The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled out again during the follow-up after the fourth week. At the end of 30 days, the program will be completed and the survey form will be received.
Control Group: No application will be performed with the participants in the control group, and these participants will be asked not to engage in regular physical activity or sports for 4 weeks and not to make any changes in their living habits.
During their follow-up two weeks later, pregnant women will be asked to bring the survey form with them. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be completed again. Participants will be informed that participants need to come for a re-check in two weeks.
The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled out again during the follow-up after the fourth week. At the end of 30 days, the program will be completed and the forms will be filled.
Evaluation of Data Evaluation of the data obtained as a result of the research will be analyzed using the SPSS (Statistical Package For Social Sciences) 25.0 package program.
Limitation of the Study: It is limited to pregnant women who applied to Şanlıurfa Training and Research Hospital affiliated with Şanlıurfa Provincial Health Directorate.
Ethical and Legal Aspects of Research Permission will be obtained from Atatürk University Clinical Research Ethics Committee before data collection. Institutional permission will be obtained from Şanlıurfa Provincial Health Directorate. Before the application, pregnant women with gestational diabetes will be informed about the purpose of the research, and if they volunteer, their verbal and written consent will be obtained through the "Informed Volunteer Consent Form".
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neslihan ATLI
- Phone Number: 05456330214
- Email: neslihanatli96@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 19-35,
- 24-28. During the pregnancy week,
- Being a single and live fetus,
- No reading and writing problems, no mental disabilities or communication problems.
Exclusion Criteria:
- Multiple pregnancy,
- Fetal congenital malformation,
- Having a diagnosed disease other than GDM
- There is a risk of miscarriage during pregnancy,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Breathing exercise will be explained to the pregnant woman, taught and applied for 5 minutes.
When doing the diaphragmatic breathing exercise, you will be told to take chest breaths after 4-5 diaphragmatic breaths to prevent hyperventilation.
Feedback will be received, questions will be answered, a training brochure will be given and the program will be completed.
Pregnant women will be asked to bring the questionnaire with them to their follow-up in two weeks.
The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be refilled.
How he did the exercise, whether he felt any effects and his satisfaction will be questioned.
Your questions will be answered.
You will be notified that you need to come for a check-up again in two weeks.
Visual Similarity Scale for Fatigue and SF-36 Quality of Life Scale will be completed.
|
It will be carried out as a randomized controlled experimental design to determine the fatigue and quality of life of pregnant women with gestational diabetes.
Other Names:
|
No Intervention: Control Group
No treatment will be performed on the participants in the control group, and they will be asked not to engage in regular physical activity or sports for 4 weeks and not to make any changes in their living habits. Pregnant women will be asked to bring the survey form with them at the follow-up visits two weeks later. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be refilled. You will be notified that you need to come for a check-up again in two weeks. At the follow-up after the fourth week, the Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled out again. At the end of thirty days, the program will be completed and the forms will be filled. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SF-36 Quality of Life Scale:
Time Frame: SF-36 Quality of Life Scale: Scale scores are expressed as a continuous variable ranging from 0 to 100. Zero indicates bad health, 100 indicates well-being.
|
Experimental group
|
SF-36 Quality of Life Scale: Scale scores are expressed as a continuous variable ranging from 0 to 100. Zero indicates bad health, 100 indicates well-being.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Similarity Scale for Fatigue
Time Frame: The highest score that can be obtained from the Fatigue subscale is 130 and the lowest score is 0. A high score from the Fatigue subscale and a low score from the Energy subscale indicate that the severity of fatigue is high.
|
Control group
|
The highest score that can be obtained from the Fatigue subscale is 130 and the lowest score is 0. A high score from the Fatigue subscale and a low score from the Energy subscale indicate that the severity of fatigue is high.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hava Özkan, Ataturk University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ataturk Unıversıty - Neslihan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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