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Completed

NCT Number: NCT04084275

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

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Levine Conservation Model Nursing Caries Nursing Model Postpartum Quality of Life

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding Education

Behavioral

personal hygiene education

Behavioral

In this training, the puerpera was informed about personal hygiene to prevent infection.

Nutrition Education

Behavioral

In this training, the amount of nutrients that breastfeeding women should take daily was explained.

fatigue education

Behavioral

In this training, suggestions were made to prevent the negative effects of fatigue

Sleep Education

Behavioral

In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.

pilates exercises education

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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. 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).

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2019
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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