Pre-Eclampsia; Complicating PregnancyNCT05863962
Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises in Preeclampsia
A study testing walking and Stretching and walking and Jacobsons relaxation technique in people with Pre-Eclampsia; Complicating Pregnancy, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pre-Eclampsia; Complicating Pregnancy
- What is being tested?
- walking and Stretching and walking and Jacobsons relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age was exceeding 24 weeks
- BP more than or up to 140/90
- Diagnosed with gestational Hypertension
- Primiparous
Who cannot join
- Women with history of preterm labor or repeated abortion
- Bleeding
- Intra uterine fetal growth anomalies
- Underlying mental (depression with severe anxiety)
- Cardio respiratory diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital
Lahore, Punjab Province, 05499
Hafiza Mahjabeen, pp-dpt, 03026577666, hafiza.mehjabeen@riphah.edu.pk
About this study
Official title: Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises on Blood Pressure and Anxiety in Preeclampsia
To compare the effect of Jacobson's Relaxation Techniques and stretching exercises on Preeclampsia in pregnant women.
Read the 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
- Conditions
- Pre-Eclampsia; Complicating Pregnancy
- Being tested
- walking and Stretching, walking and Jacobsons relaxation technique
- Keywords
- Pregnancy Toxemia,, Muscle Stretching Exercise, High Blood Pressure
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking and StretchingOther
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 techniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Stretching Exercises | Experimental | walking with stretching exercises Receives: Other: walking and Stretching |
| Jacobson's Technique | Active comparator | walking with Jacobson's Relaxation Technique. Receives: Other: walking and Jacobsons relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Weeks
Secondary outcomes (1)
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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pre-Eclampsia; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Mehjabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863962
- Sponsor's protocol ID
- REC/RCR&AHS/23/0504
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30920918Pacheco-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.
PubMed 33171282Awad 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.
PubMed 30899745Ghorbannejad 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.
PubMed 35761936Naseh, 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.
PubMed 29495906Caughey, 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 at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Jacobson's Relaxation Techniques and Stretching Exercises on Blood Pressure and Anxiety in Preeclampsia
- ClinicalTrials.gov ID
- NCT05863962
- Acronym / sponsor ID
- REC/RCR&AHS/23/0504
- Conditions
- Pre-Eclampsia; Complicating Pregnancy
- Keywords
- Pregnancy Toxemia,, Muscle Stretching Exercise, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching Exercises | Experimental | Other: walking and Stretchingwalking with stretching exercises |
| Jacobson's Technique | Active comparator | Other: walking and Jacobsons relaxation techniquewalking with Jacobson's Relaxation Technique. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age was exceeding 24 weeks
- BP more than or up to 140/90
- Diagnosed with gestational Hypertension
- Primiparous
Key exclusion criteria (5 listed)
- Women with history of preterm labor or repeated abortion
- Bleeding
- Intra uterine fetal growth anomalies
- Underlying mental (depression with severe anxiety)
- Cardio respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking and StretchingStretching 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 | Other | Stretching Exercises |
| walking and Jacobsons relaxation techniqueJacobson'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 | Other | Jacobson's Technique |
Primary outcome
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.
1 secondary outcome
Pregnancy related anxiety questionnaire
Time frame: 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 30920918Rana 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.
- BackgroundPacheco-Romero, J., Introduction to the Preeclampsia. Revista Peruana de Ginecología y Obstetricia, 2017. 63(2): p. 199-206.
- Background: PubMed 33171282Nirupama 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.
- Background: PubMed 30899745Awad 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.
- Background: PubMed 35761936Ghorbannejad 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.
- BackgroundNaseh, 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.
- BackgroundAbd 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.
- Background: PubMed 29495906Vicente 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.
- BackgroundCaughey, 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.
- BackgroundSoliman, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiza Mehjabeen principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking and Stretching and walking and Jacobsons relaxation technique in people with Pre-Eclampsia; Complicating Pregnancy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mercury sphygmomanomete (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863962, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.