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Clinical Trials/NCT05295069
NCT05295069
Completed
Not Applicable

Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study

Ataturk University1 site in 1 country112 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support
Sponsor
Ataturk University
Enrollment
112
Locations
1
Primary Endpoint
Visual Analogue Scale to Evaluate Fatigue Severity Scores
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study was designed to eliminate postpartum insomnia and fatigue and reduce the risk of postpartum depression through the maintenance of structural, personal, and social integrity with holistic care under the guidance of Levine's conservation model for primiparous puerperal women who experience fatigue and are at risk of developing depression. : A single-blind pretest-posttest randomized controlled study. Women were called to the hospital on the 7th postpartum day and randomly assigned by a computer program to either the intervention group (n=56) or the control group (n=56). Participants did not know which group they were in.

Detailed Description

A nursing care program was prepared for the intervention group under the guidance of Levine's conservation model. This program was applied with 7 home visits between the 8th and 80th postpartum days. Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed. The women in the control group received routine care. Pretest and posttest data were collected with a personal data sheet, visual analogue scale for fatigue, Postpartum Physical Symptom Severity Scale, Postpartum Sleep Quality Scale, Edinburgh Postpartum Depression Scale, and Postpartum Support Scale. Sleep quality improved for the primiparous puerperal women of the intervention group. They had reduced postpartum fatigue and increased energy; maintained their structural, personal, and social integrity; and had decreased risk of developing postpartum depression with the holistic care provided (all p\<0.001). A negative correlation was detected between the support subscale posttest total score from the Postpartum Support Scale and the posttest scores of the Edinburgh Postpartum Depression Scale for the women of the intervention group (r=-0.303; p\<0.05)

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
March 9, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulsen Eryilmaz

Prof. Dr. Gulsen ERYILMAZ

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • primiparous;
  • reading and understanding Turkish;
  • normal term delivery;
  • no risky situations during pregnancy or delivery;
  • high score (≥65 points) from the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F),
  • score of ≥12 points from the Edinburgh Postpartum Depression Scale (EPDS);
  • episiotomy;
  • hemoglobin value of at least 10.0 mg/dL;
  • no current or past history of psychiatric illness.

Exclusion Criteria

  • inability to communicate
  • unwillingness to participate in the research.

Outcomes

Primary Outcomes

Visual Analogue Scale to Evaluate Fatigue Severity Scores

Time Frame: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week

The highest score that can be obtained for the fatigue subdimension is 130 and the lowest score is 0. The highest score that can be obtained from the energy subdimension is 50 and the lowest score is 0. Higher scores on items measuring fatigue and lower scores on items measuring energy indicate that the severity of fatigue is high.

Edinburgh Postpartum Depression Scale Scores

Time Frame: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week

The highest score that can be obtained from the scale is 30. A score of 12 or more indicates that the individual is at risk of depression.

Secondary Outcomes

  • The Postpartum Physical Symptom Severity Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)
  • The Postpartum Support Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)
  • the Postpartum Sleep Quality Scale Scores(1- postpartum 8th day Time Frame: 2- Postpartum 12th week)

Study Sites (1)

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