Clinical trial NCT05709834: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood Pressure
timeFrame: 4th week
measure: Anxiety
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International university, Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Adeela Arif, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.