Can Postpartum Depression Be Prevented With Care

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support
• Intervention / Treatment: Behavioral: A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.

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)

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • AtaturkU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; To reduce postpartum depression among the primiparous puerperal women in the intervention group, and a nursing care program was implemented under the guidance of Levine's 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.	Behavioral: A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.; Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
No Intervention: The control group; In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale to Evaluate Fatigue Severity Scores	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.	1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Edinburgh Postpartum Depression Scale Scores	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.	1- 7th day after giving birth, Time Frame: 2- postpartum 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Postpartum Support Scale Scores	The lowest score that can be obtained from the scale is 0 and the highest score is 238. The higher the total score, the greater the need for support and the greater the support that needs to be received.	1- postpartum 8th day Time Frame: 2- Postpartum 12th week
the Postpartum Sleep Quality Scale Scores	The lowest and highest possible scores are respectively 0 and 56. Higher scores indicate lower sleep quality.	1- postpartum 8th day Time Frame: 2- Postpartum 12th week
The Postpartum Physical Symptom Severity Scale Scores	Total possible scores range between 0 and 54. Higher scores obtained from this scale indicate higher severity of postpartum physical symptoms.	1- postpartum 8th day Time Frame: 2- Postpartum 12th week

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): March 9, 2021

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: AtaturkU-GulsenEryilmaz-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No