- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05863962
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises on Blood Pressure and Anxiety in Preeclampsia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The effectiveness of Jacobson's progressive muscle relaxation technique on maternal, fetal, and neonatal outcomes in women with non-severe preeclampsiain have been studied in an RCT study. Pregnant women who use this technique experience reduced muscle tension and a sense of calm. in one of the study The Effect of Relaxation Techniques on Blood Pressure and Stress Among Pregnant Women with Mild Pregnancy Induced Hypertension were investigated in which Women with mild pregnancy-induced hypertension who used relaxation techniques saw significant improvements in their knowledge, physiological parameters, and blood pressure as well as a reduction in stress.
To the best of the researcher's knowledge, no comparative study has been done to yet to evaluate the efficacy of relaxation and stretching exercise. There is not enough data to determine whether Jacobson's relaxation techniques and stretching exercise reduce preeclampsia in pregnant women. As a result, this study will contribute to the expanding body of knowledge about which approach should be used as an alternative if results from other procedures are comparable
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran amjad, phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 05499
- Recruiting
- Jinnah Hospital
-
Contact:
- Hafiza Mahjabeen, pp-dpt
- Phone Number: 03026577666
- Email: hafiza.mehjabeen@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gestational age was exceeding 24 weeks
- BP more than or up to 140/90
- Diagnosed with gestational Hypertension
- Primiparous
Exclusion Criteria:
- Women with history of preterm labor or repeated abortion
- Bleeding
- Intra uterine fetal growth anomalies
- Underlying mental (depression with severe anxiety)
- Cardio respiratory diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stretching Exercises
walking with stretching exercises
|
Stretching exercise will be given for 6 weeks (3 sessions per week).
15 minutes of moderate walking with stretching exercises 5 times a week with Warm up and Cool down.
Videos will be provided to participants to follow at home.
Participants will be provided forms for home to fill after every session completed and frequency of each exercise
|
Active Comparator: Jacobson's Technique
walking with Jacobson's Relaxation Technique.
|
Jacobson's Relaxation Technique will be given for 6 weeks.
15 minutes of moderate walking with Jacobson's Relaxation Technique.
Videos will be provided to participants to follow at home.
Participants will be provided forms for home to fill after every session completed.
Participants will also bring their Pedometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mercury sphygmomanomete
Time Frame: 4 Weeks
|
patient have systolic blood pressure of 140 mm Hg or higher and/or a diastolic blood pressure of 90 mm Hg or higher.
|
4 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy related anxiety questionnaire
Time Frame: 4 Weeks
|
The degree of anxiety was estimated using Pregnancy related anxiety Questionnaire assessing the symptoms on scale 1 to 5 . 1 being not relevant and 5 relevant.
|
4 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Mehjabeen, Riphah International University
Publications and helpful links
General Publications
- Rana S, Lemoine E, Granger JP, Karumanchi SA. Preeclampsia: Pathophysiology, Challenges, and Perspectives. Circ Res. 2019 Mar 29;124(7):1094-1112. doi: 10.1161/CIRCRESAHA.118.313276. Erratum In: Circ Res. 2020 Jan 3;126(1):e8.
- Pacheco-Romero, J., Introduction to the Preeclampsia. Revista Peruana de Ginecología y Obstetricia, 2017. 63(2): p. 199-206.
- Nirupama R, Divyashree S, Janhavi P, Muthukumar SP, Ravindra PV. Preeclampsia: Pathophysiology and management. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101975. doi: 10.1016/j.jogoh.2020.101975. Epub 2020 Nov 7.
- Awad MA, Hasanin ME, Taha MM, Gabr AA. Effect of stretching exercises versus autogenic training on preeclampsia. J Exerc Rehabil. 2019 Feb 25;15(1):109-113. doi: 10.12965/jer.1836524.262. eCollection 2019 Feb.
- Ghorbannejad S, MehdizadehTourzani Z, Kabir K, MansourehYazdkhasti. The effectiveness of Jacobson's progressive muscle relaxation technique on maternal, fetal and neonatal outcomes in women with non-severe preeclampsia: a randomized clinical trial. Heliyon. 2022 Jun 13;8(6):e09709. doi: 10.1016/j.heliyon.2022.e09709. eCollection 2022 Jun.
- Naseh, Z., P. Bahadoran, and M. Valiani, Effect of Relaxation Technique on Anxiety, Stress, and Depression Scores of High-risk Pregnant Women Prone to Preeclampsia and the Physiological Indicators of Their Babies. Avicenna Journal of Nursing and Midwifery Care, 2022. 30(3): p. 211-220.
- Abd El Aliem, R.S., E.M. Abd-Elhakam, and S.A. Mustafa, Effect of Self Independence Physical Stretching Exercise on Feto-maternal Outcomes among Mild Preeclamptic Pregnant Women.
- Vicente Bertagnolli T, Souza Rangel Machado M, Ferreira CJH, Machado JSR, Duarte G, Cavalli RC. Safety of a physical therapy protocol for women with preeclampsia: a randomized controlled feasibility trial. Hypertens Pregnancy. 2018 May;37(2):59-67. doi: 10.1080/10641955.2018.1439059. Epub 2018 Mar 1.
- Caughey, M.C., et al., Abstract P035: Feasibility of Stretching Exercise for Prevention of Late-Onset Preeclampsia: A Pilot Trial. Circulation, 2018. 137(suppl_1): p. AP035-AP035.
- Soliman, G.H., S.M.A. Elalem, and S.M. Elhomosy, The effect of relaxation techniques on blood pressure and stress among pregnant women with mild pregnancy induced hypertension. Asian Journal of Nursing Education and Research, 2017. 7(3): p. 321-329.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0504
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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