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

Not Applicable

Completed

• Conditions: Nursing Caries; Postpartum; Breastfeeding; Quality of Life; Nursing Model; Levine Conservation Model
• Interventions: Behavioral: breastfeeding education; Behavioral: personal hygiene education; Behavioral: nutrition education; Behavioral: fatigue education; Behavioral: sleep education; Behavioral: pilates exercises education

• Registration Number: NCT04084275
• Lead Sponsor: Erzincan University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

Not provided

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Exclusion Criteria

• those who do not meet the eligibility criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	personal hygiene education	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
experimental group	nutrition education	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
experimental group	breastfeeding education	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
experimental group	sleep education	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
experimental group	pilates exercises education	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
experimental group	fatigue education	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

Primary Outcome Measures

Name	Time	Method
Fatigue assessed by Visual Analogue Scale for Fatigue	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).
Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref)	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)
Sleep quality assessed by Pittsburg Sleep Quality Index	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).