A randomized controlled trial to evaluate the effectiveness of selected multicomponent nursing interventions on quality of life and birth outcomes of pregnant women.

“A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THEEFFECTIVENESS OF SELECTED MULTICOMPONENT NURSING INTERVENTIONS ON QUALITY OFLIFE AND BIRTH OUTCOMES OF PREGNANT WOMEN AT MATERNITY HOSPITALS, JODHPUR(RAJASTHAN)â€.

Background of the study

Pregnancyis a physiological event, and it creates an important burden and stress for thefemale body. The expectant mother experiences many anatomical, physiological,psychological and biochemical changes to meet developing fetal demands, toprotect homeostasis, to prepare for birth and lactation. These changes canaffect the quality of life (QOL) of pregnant women, affecting both maternal andinfant health. Maternal stress may increase the level of corticotrophinreleasing hormone (CRH) in pregnancy that might lead to premature delivery.This may in-turn prove fatal and result in harming the child itself 3.

Accordingto SRS 2016-18 MMR of India is 113 and in Rajasthan MMR is 164. In 2018, Peri-natal mortality rate of India was 22 and inRajasthan it was 26. In India neonatal mortality rate is 23 and earlyneonatal mortality rate is 18. Neonatal mortality rate is 26 and early neonatalmortality rate is 20 in Rajasthan 4.

AIM AND OBJECTIVES

AIM:

This study aims to evaluate the effectiveness ofselected multicomponent nursing interventions on quality of life and birthoutcomes of pregnant women at maternity hospitals, Jodhpur (Rajasthan).

PRIMARY OBJECTIVE:

1.     To assess and compare quality of life scoreafter 10 weeks of follow-up in experimental and control group.

SECONDARY OBJECTIVES:

1.     To find out association of quality of lifescore with birth outcomes (birth weight, duration of pregnancy, mode ofdelivery and APGAR score) in experimental and control group.

2    Toassess quality of life score of pregnant women (21-24 weeks of gestation) atrecruitment and find out its association with demographic variables (age,habitat, qualification, marital status, type of family, occupation, family monthlyincome, dietary pattern, substance abuse, gravida status and biologicalvariable).

MATERIALS AND METHODOLOGY

PLACE OF STUDY:

Thestudy will be conducted at Maternity hospitals (Umaid Hospital and MDMHospital), Jodhpur (Rajasthan)

STUDY POPULATION/ SAMPLE**:**

Pregnantwomen attending antenatal OPD in II trimester (21-24 weeks of gestation) atselected maternity hospitals, Jodhpur (Rajasthan) will be taken up for thestudy after obtaining a written informed consent.

RESEARCH APPROACH:

Quantitativeexperimental research approach will be used.

STUDY DESIGN:

Openlabel Randomized Controlled Trial will be used for the study.

PERIOD OF STUDY:

Thestudy will start after the permission from IEC and will take approximately12-14 months. Another two months will be required for analysis of data andwriting the thesis.

SAMPLE SELECTION CRITERIA:

InclusionCriteria:

•        Pregnant women who will beattending antenatal OPD in II trimester (21-24 weeks of gestation) at maternityhospitals, Jodhpur.

•        Pregnant women between the ageof 18 - 40 years.

•        Pregnant women of primi orsecundigravida status.

•        Pregnant women who will beable to read, write and understand Hindi or English or local language.

•        Pregnant women who will bewilling to participate in the research study.

ExclusionCriteria:

·       Pregnant women who will behaving high-risk pregnancy.

•        Pregnant women withpsychiatric illness such as severe stress and anxiety, mental retardation,depression, personality disorders etc.

•        Premature delivery prior tocompletion of the follow-up period.

Variables under study-

•        Dependentvariable:   Quality of life of Pregnant women and birth outcomes(birth weight, duration of pregnancy, mode of delivery and APGAR score)

•        Independent variable:Multicomponent Nursing Interventions

•        Attributevariable: Age in years, habitat, qualification, marital status, type of family,occupation, family monthly income, dietary pattern, substance abuse, gravidastatus, and biological variable.

Tool for data collection

•        The tool comprises ofthree parts: -

Part-I: Socio-demographic proformaand biological variable

Age in years, habitat,qualification, marital status, type of family, occupation, family monthlyincome, dietary pattern, substance abuse, gravida status, and biologicalvariable (height of the pregnant woman, weight, Hb% and BMI)

Part-II: Quality of life scalestandardized tool RAND 36- Item short FormSurvey (SF-36)

**Part-III: Birth outcomes:**it will be collected after delivery of the newborn.

•        Newbornbirth weight

•        Durationof pregnancy

•        Modeof delivery

•        APGARScore of newborn at 5 minutes after birth

Intervention of the study

1. Multicomponent nursing interventions include: -

2. Psychoeducation (Nutrition, activities of daily living, danger signals during pregnancy & labour, body image & appearance, self-esteem, personal belief and thinking, emotional aspect, domestic and sexual violence, engagement in social events & activities, substance abuse, recreational activities, arrangements of facilities and various programmes run by government)

3. Antenatal exercises (walking, pelvic floor exercise, ankle exercise, breathing exercise)

4. Relaxation techniques (Jacobson progressive muscle relaxation technique)

Data collection procedure

The study will be conducted in4 phases: -

1. Pre-test on quality of life after taking informed consent (21-24 weeks of gestation)

2. Sociodemographic variables

3. RAND 36- Item Short Form Survey (SF-36)

II.     Applicationof selected multicomponent nursing interventions to experimental group.

III.   Post-testassessment of quality of life (31-34 weeks of gestation)

A.    RAND 36- ItemShort Form Survey (SF-36)

IV.    Assessmentof birth outcomes (after delivery of the newborn)

A.          Birthoutcomes