Clinical trial NCT05295069: Can Postpartum Depression Be Prevented With Care
Official title: Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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.

Primary outcomes:
measure: Visual Analogue Scale to Evaluate Fatigue Severity Scores
timeFrame: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
measure: Edinburgh Postpartum Depression Scale Scores
timeFrame: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Secondary outcomes:
measure: The Postpartum Support Scale Scores
timeFrame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
measure: the Postpartum Sleep Quality Scale Scores
timeFrame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
measure: The Postpartum Physical Symptom Severity Scale Scores
timeFrame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: AtaturkU
Study officials:
References: