Autogenic Training Effects on Pre-eclampsia

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05709834
Collaborator
(none)
26
1
2
12.6
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Autogenic training
  • Other: Conventional treatment
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Autogenic Training on Blood Pressure and Anxiety in Females With Pre-eclampsia
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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

Other: Control group

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

Other: Conventional treatment
Patients will receive conventional treatment
Other Names:
  • Control group
  • Outcome Measures

    Primary Outcome Measures

    1. Blood Pressure [4th week]

      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.

    2. Anxiety [4th week]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riphah International university, Lahore Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Adeela Arif, Mphil, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05709834
    Other Study ID Numbers:
    • Adeela
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2023