Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social SupportNCT05295069
Can Postpartum Depression Be Prevented With Care
A study testing A nursing care program was applied for the intervention group under the guidance of Levine's conservation model. in people with Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support
- What is being tested?
- A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 9 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- episiotomy;
- hemoglobin value of at least 10.0 mg/dL;
- no current or past history of psychiatric illness.
Who cannot join
- inability to communicate
- unwillingness to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.Behavioural
Face-to-face training and training booklets were provided in home visits. As of the fourth home visit, Pilates exercises were performed.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | 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. Receives: Behavioral: A nursing care program was applied for the intervention group under the guidance of Levine's conservation model. |
| The control group | No intervention | In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Jul 2019
- Primary completion1 Apr 2020
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsen Eryilmaz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295069
- Sponsor's protocol ID
- AtaturkU-GulsenEryilmaz-001
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Postpartum Depression Be Prevented With Care Provided To Primiparas Using Levine's Conservation Model: Single-Blind Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT05295069
- Acronym / sponsor ID
- AtaturkU-GulsenEryilmaz-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: A nursing care program was applied for the intervention group under the guidance of Levine's conservation model.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. |
| The control group | No intervention | –In the control group women received routine postpartum care. No interventions were conducted other than routine postpartum care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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),
Key exclusion criteria (2 listed)
- inability to communicate
- unwillingness to participate in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | The intervention group |
Primary outcome
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.
3 secondary outcomes
The Postpartum Support Scale Scores
Time frame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
the Postpartum Sleep Quality Scale Scores
Time frame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
The Postpartum Physical Symptom Severity Scale Scores
Time frame: 1- postpartum 8th day Time Frame: 2- Postpartum 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A nursing care program was applied for the intervention group under the guidance of Levine's conservation model. in people with Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale to Evaluate Fatigue Severity Scores (time frame: 1- 7th day after giving birth, Time Frame: 2- postpartum 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.