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Autogenic Training Effects on Pre-eclampsia

Primary Purpose

Pre-Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Autogenic training
Conventional treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International university, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Autogenic training

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Blood Pressure
The sphygmomanometer is an objective tool used to measure the blood pressure.it consist of the inflatable rubber cuff, which is wrapped around the upper arm connected to an appratus that records pressure. The sounds are detected by the doctor using a stethoscope.it is also called blood pressure gauge The validity or specificity of sphygnomanometer is 0.7.
Anxiety
The Depression Anxiety Stress Scales (DASS-21) was designed to measure the core symptoms of depression, anxiety and stress and has demonstrated excellent psychometric properties across studies. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness and lack of interest. The anxiety scale assesses autonomic arousal, skeletal muscle effects and situational anxiety and the stress scale assesses difficulty relaxing, agitated, and impatient. The validity of scale is 0.90.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05709834
Brief Title
Autogenic Training Effects on Pre-eclampsia
Official Title
Effects of Autogenic Training on Blood Pressure and Anxiety in Females With Pre-eclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
February 25, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autogenic training
Arm Type
Experimental
Arm Description
It consists of patients who will receive autogenic training and conventional treatment with the frequency of 3 times per week for 4 weeks.
Arm Title
Control group
Arm Type
Other
Arm Description
Its consists of patients who will receive conventional treatment with the frequency of 3 sessions per week
Intervention Type
Other
Intervention Name(s)
Autogenic training
Intervention Description
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
Intervention Name(s)
Conventional treatment
Other Intervention Name(s)
Control group
Intervention Description
Patients will receive conventional treatment
Primary Outcome Measure Information:
Title
Blood Pressure
Description
The sphygmomanometer is an objective tool used to measure the blood pressure.it consist of the inflatable rubber cuff, which is wrapped around the upper arm connected to an appratus that records pressure. The sounds are detected by the doctor using a stethoscope.it is also called blood pressure gauge The validity or specificity of sphygnomanometer is 0.7.
Time Frame
4th week
Title
Anxiety
Description
The Depression Anxiety Stress Scales (DASS-21) was designed to measure the core symptoms of depression, anxiety and stress and has demonstrated excellent psychometric properties across studies. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness and lack of interest. The anxiety scale assesses autonomic arousal, skeletal muscle effects and situational anxiety and the stress scale assesses difficulty relaxing, agitated, and impatient. The validity of scale is 0.90.
Time Frame
4th week

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeela Arif, Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International university, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
30739345
Citation
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.
Results Reference
background
PubMed Identifier
30009746
Citation
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.
Results Reference
background
PubMed Identifier
26257800
Citation
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.
Results Reference
background
PubMed Identifier
30985405
Citation
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.
Results Reference
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Autogenic Training Effects on Pre-eclampsia

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