Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia
Primary Purpose
Pre-Eclampsia; Complicating Pregnancy
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
walking and Stretching
walking and Jacobsons relaxation technique
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Eclampsia; Complicating Pregnancy focused on measuring Pregnancy Toxemia,, Muscle Stretching Exercise, High Blood Pressure
Eligibility Criteria
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
Sites / Locations
- Jinnah HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stretching Exercises
Jacobson's Technique
Arm Description
walking with stretching exercises
walking with Jacobson's Relaxation Technique.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05863962
First Posted
May 9, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05863962
Brief Title
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia
Official Title
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises on Blood Pressure and Anxiety in Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia; Complicating Pregnancy
Keywords
Pregnancy Toxemia,, Muscle Stretching Exercise, High Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stretching Exercises
Arm Type
Experimental
Arm Description
walking with stretching exercises
Arm Title
Jacobson's Technique
Arm Type
Active Comparator
Arm Description
walking with Jacobson's Relaxation Technique.
Intervention Type
Other
Intervention Name(s)
walking and Stretching
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
walking and Jacobsons relaxation technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Mercury sphygmomanomete
Description
patient have systolic blood pressure of 140 mm Hg or higher and/or a diastolic blood pressure of 90 mm Hg or higher.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Pregnancy related anxiety questionnaire
Description
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.
Time Frame
4 Weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PHD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
05499
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mahjabeen, pp-dpt
Phone
03026577666
Email
hafiza.mehjabeen@riphah.edu.pk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30920918
Citation
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.
Results Reference
background
Citation
Pacheco-Romero, J., Introduction to the Preeclampsia. Revista Peruana de Ginecología y Obstetricia, 2017. 63(2): p. 199-206.
Results Reference
background
PubMed Identifier
33171282
Citation
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.
Results Reference
background
PubMed Identifier
30899745
Citation
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.
Results Reference
background
PubMed Identifier
35761936
Citation
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.
Results Reference
background
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
29495906
Citation
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
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Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia
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