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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05863962
Other study ID # REC/RCR&AHS/23/0504
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date August 1, 2023

Study information

Verified date May 2023
Source Riphah International University
Contact Imran Amjad, PHD
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date August 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
walking and Stretching
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
walking and Jacobsons 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

Locations

Country Name City State
Pakistan Jinnah Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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.

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. — View Citation

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.

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. — View Citation

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.

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. — View Citation

Pacheco-Romero, J., Introduction to the Preeclampsia. Revista Peruana de Ginecología y Obstetricia, 2017. 63(2): p. 199-206.

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. — View Citation

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mercury sphygmomanomete 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 Pregnancy related anxiety questionnaire 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
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