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Can Postpartum Depression Be Prevented With Care

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • AtaturkU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The intervention group

The control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
the Postpartum Sleep Quality Scale Scores
The lowest and highest possible scores are respectively 0 and 56. Higher scores indicate lower sleep quality.
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.

Full Information

First Posted
March 9, 2022
Last Updated
March 21, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05295069
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
All participants did not know which group they were in.
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care.
Intervention Type
Behavioral
Intervention Name(s)
A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
Intervention Description
Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
Primary Outcome Measure Information:
Title
Visual Analogue Scale to Evaluate Fatigue Severity Scores
Description
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.
Time Frame
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Title
Edinburgh Postpartum Depression Scale Scores
Description
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.
Time Frame
1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Secondary Outcome Measure Information:
Title
The Postpartum Support Scale Scores
Description
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.
Time Frame
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Title
the Postpartum Sleep Quality Scale Scores
Description
The lowest and highest possible scores are respectively 0 and 56. Higher scores indicate lower sleep quality.
Time Frame
1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Title
The Postpartum Physical Symptom Severity Scale Scores
Description
Total possible scores range between 0 and 54. Higher scores obtained from this scale indicate higher severity of postpartum physical symptoms.
Time Frame
1- postpartum 8th day Time Frame: 2- Postpartum 12th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
AtaturkU
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available

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Can Postpartum Depression Be Prevented With Care

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