NCT05709834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

January 4, 2023

Last Update Submit

June 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    4th week

  • 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.

    4th week

Study Arms (2)

Autogenic training

EXPERIMENTAL

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

Control group

OTHER

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

Other: Conventional treatment

Interventions

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

Autogenic training

Patients will receive conventional treatment

Also known as: Control group
Control group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women with cardiorespiratory diseases and diabetes
  • Previous history of preterm labor or abortion
  • History of serious mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 30899745BACKGROUND
  • 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.

    PMID: 30739345BACKGROUND
  • 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.

    PMID: 30009746BACKGROUND
  • 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.

    PMID: 26257800BACKGROUND
  • 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.

    PMID: 30985405BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Autogenic TrainingControl Groups

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Adeela Arif, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

February 2, 2023

Study Start

January 15, 2022

Primary Completion

February 25, 2023

Study Completion

March 15, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations