- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07630623
Effects of Progressive Muscle Relaxation Exercise and Finger Grip Exercise on Stress, Anxiety, Fatigue, Sleep Quality, and Physiological Parameters in Pregnant Women With Preeclampsia
The Effects of Progressive Muscle Relaxation Exercise and Finger Grip Exercise on Stress, Anxiety, Fatigue, Sleep Quality, and Physiological Parameters in Pregnant Women With Preeclampsia
The aim of this study is to examine the effects of progressive muscle relaxation exercise and finger grip exercise on stress, anxiety, sleep quality, fatigue and physiological parameters in preeclamptic pregnant women. It is thought that the study will contribute to the improvement of sleep quality by reducing the stress, anxiety and fatigue levels of pregnant women. In this study, which will examine the effects of stress, anxiety, fatigue, sleep quality and physiological parameters of preeclamptic pregnant women, progressive muscle relaxation exercise and finger grip exercise will be used in the same study. No other study has been found where these two methods were used in the same study and the specified parameters were examined together. It is thought that the results of this study will contribute to the literature.
The basic questions that the study will answer are as follows:
H1: The stress level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group.
H2: The anxiety level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group.
H3: The fatigue level of preeclamptic pregnant women in the progressive muscle relaxation exercise group is lower than that of the control group.
H4: The sleep quality of preeclamptic pregnant women in the progressive muscle relaxation exercise group is better than that of the control group.
H5: The physiological parameters of preeclamptic pregnant women in the progressive muscle relaxation exercise group are better than that of the control group.
H6: The stress level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group.
H7: The anxiety level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group.
H8: The fatigue level of preeclamptic pregnant women in the finger grip exercise group is lower than that of the control group.
H9: The sleep quality of preeclamptic pregnant women in the finger grip exercise group is better than the control group.
H10: The physiological parameters of preeclamptic pregnant women in the finger grip exercise group are better than the control group.
H11: The effects of progressive muscle relaxation exercise and finger grip exercise on stress levels are different in preeclamptic pregnant women.
H12: The effects of progressive muscle relaxation exercise and finger grip exercise on anxiety levels are different in preeclamptic pregnant women.
H13: The effects of progressive muscle relaxation exercise and finger grip exercise on fatigue levels are different in preeclamptic pregnant women.
H14: The effects of progressive muscle relaxation exercise and finger grip exercise on sleep quality are different in preeclamptic pregnant women.
H15: The physiological parameters of progressive muscle relaxation exercise and finger grip exercise are different in preeclamptic pregnant women.
Researchers will divide participants into experimental and control groups to examine the effects of progressive muscle relaxation exercise and finger grip exercise on stress, anxiety, sleep quality, fatigue and physiological parameters in pregnant women with preeclampsia. There will be 3 groups in the study.
Group 1: PKGE Group Group 2: Finger Grip Group Group 3: Control Group
Progressive muscle relaxation exercise will be applied to group 1, finger grip exercise will be applied to group 2, and no intervention will be applied to group 3.
The data of the study will be collected with the Perceived Stress Scale, State/Trait Anxiety Scale, Richard-Campbell Sleep Scale, Visual Similarity Scale for Fatigue, Physiological Parameters, VAS Score Average.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Altinordu
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Ordu, Altinordu, Turkey (Türkiye), 52100
- Ordu Üniversitesi Eğitim ve Araştırma Hastanesi Kadın Doğum ve Çocuk Hastalıkları Hastanesi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Diagnosed with preeclampsia
- In their 20th week of pregnancy or older
- Know and speak Turkish
- Have at least primary school education
- Have a singleton pregnancy
- Voluntarily and agree to participate in the study will be included in the study.
Exclusion Criteria:
• Pregnant women who have been diagnosed with a mental illness and who have begun labor while the study is ongoing will be excluded..
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Finger Grip Exercise
FINGER GRIP EXERCISE WILL BE APPLIED TO THIS GROUP.
|
Fingers are connected to energy channels in the body, the nervous system, and the brain.
Holding specific fingers can help calm the energy channel and brain area associated with the finger.
These finger grips can be performed for oneself or for someone else (Weirich, 2021).
The finger grip technique will be applied to preeclamptic pregnant women in the intensive care unit once for 20 minutes during their day of admission, and post-test data will be collected three hours after the procedure.
|
|
No Intervention: Control Group
NO INTERVENTION WILL BE MADE TO THIS GROUP.
|
|
|
Experimental: PKGE Group
PROGRESSIVE MUSCLE RELAXATION EXERCISE WILL BE APPLIED TO THIS GROUP.
|
A pre-test will be applied to the progressive muscle relaxation exercise, finger grip and control groups of the study.
The data of the study will be collected 3 hours after the women in the progressive muscle relaxation exercise and finger grip exercise groups do 20 minutes of exercise.
No intervention will be made to the control group.
After the data of the study is collected, a post-test will be applied to both the experimental and control groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
STATISTICAL DIFFERENCES BETWEEN EXPERIMENTAL AND CONTROL GROUPS
Time Frame: It takes approximately one year to complete the study.
|
Frequency of stress, anxiety, and fatigue in pregnant women with preeclampsia.
Definition of sleep quality and variability of physiological parameters.
|
It takes approximately one year to complete the study.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
STATISTICAL DIFFERENCES BETWEEN THE CONTROL GROUP AND THE OTHER TWO GROUPS
Time Frame: It takes approximately one year to complete the study.
|
No intervention will be made to the control group, and the other two groups will be treated. Frequency of stress, anxiety, and fatigue in pregnant women with preeclampsia. Definition of sleep quality and variability of physiological parameters. |
It takes approximately one year to complete the study.
|
|
STATISTICAL DIFFERENCES BETWEEN THE CONTROL GROUP AND THE OTHER TWO GROUPS
Time Frame: It takes approximately one year to complete the study.
|
Frequency of stress, anxiety, and fatigue in pregnant women with preeclampsia.
Definition of sleep quality and variability of physiological parameters.
|
It takes approximately one year to complete the study.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nülüfer ERBİL, Prof.Dr, Ordu Üniversitesi Sağlık Bilimleri Fakültesi Dekanlığı
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001093483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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