Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes

NCT06265935 | Not Yet Recruiting

• 1 other identifier: Ataturk Unıversıty - Neslihan
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Pregnancy in Diabetic; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (1)

• SF-36 Quality of Life Scale:

  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 Outcomes (1)

• Visual Similarity Scale for Fatigue

  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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Experimental Group

Control Group

NO INTERVENTION

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.

Interventions

Experimental Group BEHAVIORAL

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.

Also known as: Control Group

Experimental Group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 19-35,
• During the pregnancy week,
• Being a single and live fetus,
• No reading and writing problems, no mental disabilities or communication problems.

You may not qualify if:

• Multiple pregnancy,
• Fetal congenital malformation,
• Having a diagnosed disease other than GDM
• There is a risk of miscarriage during pregnancy,

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Pregnancy in Diabetics; Fatigue

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hava Özkan

  Ataturk University

  STUDY CHAIR

Central Study Contacts

Neslihan ATLI

CONTACT

05456330214; neslihanatli96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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, and 30 pregnant women diagnosed with gestational diabetes who are applied diaphragmatic breathing exercise and who are not applied diaphragmatic breathing exercise.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: midwife

Model Details: Randomize

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: March 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: October 15, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share