Can Postpartum Depression Be Prevented With Care

NCT ID: NCT05295069

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-03-09

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)

Conditions

Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.

Intervention Type: BEHAVIORAL

Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.

The control group

In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Gulsen Eryilmaz

Prof. Dr. Gulsen ERYILMAZ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AtaturkU

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AtaturkU-GulsenEryilmaz-001

Identifier Type: -

Identifier Source: org_study_id