The Effect of Care Given Using Levine's Conservation Model on Postpartum Quality of Life in Primiparas

September 6, 2019 updated by: Şadiye Özcan, Erzincan University

Background: Postpartum period is a physiologically, emotionally and socially critical period for the woman who gave birth and also for their family. In order for women to go through their postpartum period without any problems, be able to perform self-care and have an unaffected quality of life, they need qualified, comprehensive and integrative nursing care.

Aim and objectives: This study aimed to investigate the effect of care given using Levine's conservation model on postpartum quality of life in primiparae.

Design: A randomized controlled trial. Methods: Levine's conservation model was used as the theoretical framework for this study. A literature review was used to determine the contents of the intervention program. The program consisted of 8 sessions. The puerpera were given trainings on different subjects based on the module during each session. For these trainings, the researcher prepared, in the light of the literature data, leaflets containing information about breastfeeding, personal hygiene, fatigue, nutrition and pilates exercises. The puerpera in the control group received only the standard nursing care given after birth. Standard nursing care contain solely breastfeeding training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

The study included puerpera who

  • were in the 18-35 age interval and were at least a primary school graduate,
  • had no loss of their senses of vision or hearing,
  • were open to communication and cooperation,
  • had a nuclear type of family,
  • were able to understand and read Turkish,
  • were primiparae,
  • had a full-term (between weeks 38-42) vaginal delivery,
  • had a haemoglobin value of at least 10 mg/dl,
  • experienced no risky conditions during gestation (placenta previa, pre-eclampsia, any systemic ailment) or during delivery (ablatio placenta, dystocia, etc.),
  • were administered mediolateral episiotomy (because episiotomy impair the integrity of tissue. Healing such episiotomy incisions as soon as possible is quite important to conserve structural integrity).

Exclusion Criteria:

- those who do not meet the eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental group
Levine's conservation model was used as the theoretical framework for this study. A literature review was used to determine the contents of the intervention program. A nursing care program which consisted of 8 sessions, the first of which was at the hospital and the others at the homes of puerpera and which were held at different times and lasted 12 weeks in total, based on Levine's Conservation Model was provided to the women in the intervention group. Each session lasted approximately 60-120 minutes, according to the educational and practical contents.The puerpera were given trainings on different subjects based on the module during each session. For these trainings, the investigators prepared, in the light of the literature data, leaflets containing information about breastfeeding, personal hygiene, fatigue, nutrition and pilates exercises
Behavioral: breastfeeding education
Behavioral: personal hygiene education
In this training, the puerpera was informed about personal hygiene to prevent infection.
Behavioral: nutrition education
In this training, the amount of nutrients that breastfeeding women should take daily was explained.
Behavioral: fatigue education
In this training, suggestions were made to prevent the negative effects of fatigue
Behavioral: sleep education
In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.
Behavioral: pilates exercises education
In this study, pilates exercises exclusively for postpartum women were selected from two reference books, Fitness Professional's Handbook and Guide Women's and Fitness Health, which include 13 movements: Bridging, Hundred, Roll Up, One Leg Circle (both ways), Rocker with close legs,Single Straight Leg Stretch, Double Leg Stretch, Spine Stretch Forward, Single Leg Kick, Side Kick up and down, Side Kick circles, Rest position (stretch and relaxation) and Curling. The trainings were provided by the investigator during home visits to the puerpera in the intervention group and the pilates exercises by the investigator who was also a pilates trainer. An appropriate setting was prepared at the homes of puerpera so that they could do the pilates exercises easily.
NO_INTERVENTION: control group
The puerpera in the control group received only the standard nursing care given after birth. Standard nursing care contain solely breastfeeding training. The puerpera in the control group were visited before they were discharged from the hospital to obtain their contact information and to administer them the pretest. A home visit at the end of postpartum month 3 was also planned and they were administered the posttest. After collecting the posttest data, the trainings given to the women in the intervention group on nutrition, sleep, fatigue and pilates exercises were also given to the women in the control group in consideration of the ethical dimension of the study; they were actively trained on pilates exercises by the investigator and the relevant leaflets were given to them by the end of their trainings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref)
Time Frame: 3 months
It is a multi-dimensional measurement tool designed by the World Health Organization to assess quality of life of individuals. The short form of the scale contains four domains and another domain where overall quality of life is evaluated. The domains are physical health, psychological health, social relationships, environment and general health. Each item in the scale is scored as a 5-point rating. Each domain assesses quality of life within itself independent of the others. Higher scores obtained in this scale indicate better quality of life. A study concluded that the short form of the scale was a valid and reliable instrument for the postpartum period. The validity and reliability study of the scale was performed in 1999 to be able to use it in Turkey and the Cronbach's α reliability coefficient of the scale was found to be 0.76 (Eser et al. 1999)
3 months
Fatigue assessed by Visual Analogue Scale for Fatigue
Time Frame: 3 months
Developed by Lee et al. in 1991, the scale is used to measure the level of fatigue in healthy and ill individuals. Consisting of 18 items in total, the scale has 13 items to measure the level of fatigue and 5 items to measure the level of energy. There is a 10-cm horizontal line for each item of the scale with positive expressions on one end and negative on the other. Those who complete the scale are asked to mark the point which reflects best the feeling they had when they read the statement in the scale. Afterwards, the points of intersection at the places marked are measured with a ruler one by one for each question and evaluated objectively. Higher scores obtained from the fatigue items and lower scores obtained from the energy items indicate higher severity of fatigue. The validity and reliability study of the scale in Turkey and the Cronbach's α internal consistency coefficient of was found to be 0.90 (Yurtsever and Bedük, 2003).
3 months
Sleep quality assessed by Pittsburg Sleep Quality Index
Time Frame: 3 months
Developed by Buysse and associates (1989), the index shows the sleep quality of an individual over the last month as stated by them. There are 19 questions in the index relating to sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction. Each question in the index is scored from 0 to 3. Zero shows having no trouble and 3 having serious trouble sleeping. Higher total scores indicate poorer sleep quality. The validity and reliability study of the index was performed in 1996 to be able to use it in Turkey and the Cronbach's α reliability coefficient of the index was found to be 0.80 (Ağargün et al.1996).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Investigators

  • Principal Investigator: ŞADİYE ÖZCAN, Doctor, Erzincan university faculty of health sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

3 months

IPD Sharing Access Criteria

no criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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