Clinical trial NCT04084275: The Effect of Care Given Using Levine's Conservation Model on Postpartum Quality of Life in Primiparas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Quality of Life
Nursing Caries
Postpartum
Nursing Model
Levine Conservation Model
Keywords: nursing care
Levine's conservation model
postpartum care
postpartum quality of life
postpartum problems
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life assessed by World Health Organization Quality of Life Assessment Instrument (WHOQOL-Bref)
timeFrame: 3 months
measure: Fatigue assessed by Visual Analogue Scale for Fatigue
timeFrame: 3 months
measure: Sleep quality assessed by Pittsburg Sleep Quality Index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Erzincan university faculty of health sciences
name: ŞADİYE ÖZCAN, Doctor
role: PRINCIPAL_INVESTIGATOR
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