Autogenic Training Effects on Pre-eclampsia

NCT ID: NCT05709834

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-03-15

Brief Summary

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The purpose of study is to find the effects of autogenic training on blood pressure and anxiety in preeclampsia females. There is little of evidence to allow conclusions about effectiveness of autogenic training on preeclampsia Therefore this study will add to the growing body of knowledge that if autogenic training is better than any other protocol for preeclampsia and anxiety then it should be a choice of therapy treatment. This study can provide help pregnant females and other society members to think about treatment of preeclampsia and anxiety other than medical approach.

Detailed Description

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Pre-eclampsia is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. When it arises, the condition mostly begins after 20 weeks of pregnancy. In severe cases of the disease there may be red blood cell breakdown, a low blood platelet count, impaired liver function, kidney dysfunction, swelling, shortness of breath due to fluid in the lungs, or visual disturbances. Pre-eclampsia increases the risk of undesirable outcomes for both the mother and the fetus. Pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. Pre-eclampsia is much more common in women who are pregnant for the first time or have obesity, diabetes and autoimmune disease.

Randomized controlled trial (RCT) will be conducted to find the effects of autogenic training on blood pressure and anxiety in females having pre-eclampsia, the data will be collected from National Hospital and Sofia clinic via sphygmomanometer and DASS-21 scale. Sample size of 26 females is taken. Non probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lo1.ttery method to either Group A or Group B. Treatment will be given 3 times per week for 4 weeks. Sphygmomanometer will be used to check the blood pressure reading and DASS-21 questionnaire will be used to access anxiety in the females. All participants in both groups will be evaluated before and after the treatment program. Total duration of the study will be ten months. Data will be analyzed by using SPSS 21.

Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autogenic training

It consists of patients who will receive autogenic training and conventional treatment with the frequency of 3 times per week for 4 weeks.

Group Type EXPERIMENTAL

Autogenic training

Intervention Type OTHER

Relaxation procedures will be performed in the following steps: First step - preparation: Each pre-eclamptic woman will be instructed about this method of treatment and its importance for reducing blood pressure to gain her confidence and cooperation during treatment. Second step - AT: The session began with a few minutes of mental relaxation as the patient will be asked to imagine herself in a lovely place that makes her relaxed. Each session include 18 exercises combining both relaxation and auto-suggestion (limb heaviness exercise, limb warmth exercise, cardiac exercise, respiration exercise, solar plexus warmth exercise, and "forehead cooling" exercise).

About 30 sec will be allowed for each exercise and a further 30-40 sec will allowed for continuing attention focusing by the patient. Third step - termination

Control group

Its consists of patients who will receive conventional treatment with the frequency of 3 sessions per week

Group Type OTHER

Conventional treatment

Intervention Type OTHER

Patients will receive conventional treatment

Interventions

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Autogenic training

Relaxation procedures will be performed in the following steps: First step - preparation: Each pre-eclamptic woman will be instructed about this method of treatment and its importance for reducing blood pressure to gain her confidence and cooperation during treatment. Second step - AT: The session began with a few minutes of mental relaxation as the patient will be asked to imagine herself in a lovely place that makes her relaxed. Each session include 18 exercises combining both relaxation and auto-suggestion (limb heaviness exercise, limb warmth exercise, cardiac exercise, respiration exercise, solar plexus warmth exercise, and "forehead cooling" exercise).

About 30 sec will be allowed for each exercise and a further 30-40 sec will allowed for continuing attention focusing by the patient. Third step - termination

Intervention Type OTHER

Conventional treatment

Patients will receive conventional treatment

Intervention Type OTHER

Other Intervention Names

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Control group

Eligibility Criteria

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Inclusion Criteria

* Diagnose Women with pre-eclampsia
* Blood pressure value more than 90/140
* 2nd trimester
* Age of 25 to 35 years

Exclusion Criteria

* Women with cardiorespiratory diseases and diabetes
* Previous history of preterm labor or abortion
* History of serious mental illness
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adeela Arif, Mphil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International university, Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30899745 (View on PubMed)

Lu HQ, Hu R. The role of immunity in the pathogenesis and development of pre-eclampsia. Scand J Immunol. 2019 Nov;90(5):e12756. doi: 10.1111/sji.12756. Epub 2019 Sep 9.

Reference Type BACKGROUND
PMID: 30739345 (View on PubMed)

Soto-Balbuena C, Rodriguez MF, Escudero Gomis AI, Ferrer Barriendos FJ, Le HN, Pmb-Huca G. Incidence, prevalence and risk factors related to anxiety symptoms during pregnancy. Psicothema. 2018 Aug;30(3):257-263. doi: 10.7334/psicothema2017.379.

Reference Type BACKGROUND
PMID: 30009746 (View on PubMed)

Abedian Z, Soltani N, Mokhber N, Esmaily H. Depression and anxiety in pregnancy and postpartum in women with mild and severe preeclampsia. Iran J Nurs Midwifery Res. 2015 Jul-Aug;20(4):454-9. doi: 10.4103/1735-9066.161013.

Reference Type BACKGROUND
PMID: 26257800 (View on PubMed)

Horsley KJ, Tomfohr-Madsen LM, Ditto B, Tough SC. Hypertensive Disorders of Pregnancy and Symptoms of Depression and Anxiety as Related to Gestational Age at Birth: Findings From the All Our Families Study. Psychosom Med. 2019 Jun;81(5):458-463. doi: 10.1097/PSY.0000000000000695.

Reference Type BACKGROUND
PMID: 30985405 (View on PubMed)

Other Identifiers

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Adeela

Identifier Type: -

Identifier Source: org_study_id

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