- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05533021
Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers
Impact of the Training Structured According to Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tokat, Turkey, 60250
- Tokat Gaziosmanpasa University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Mothers with the following criteria were included in the study;
- Primiparous
- Cesarean delivery
- Over 18 years old
- At least primary school graduate
- Communicating verbally
- Using mobile phone and whatsapp application
- Married and living with spouse
Exclusion Criteria: Mothers with the following criteria were excluded from the study;
- Having a risky pregnancy history
- Having a history of chronic disease
- Diagnosed with a psychiatric illness
- Having a health problem in herself or her baby that requires separation from each other
- Having a baby with any congenital anomaly or severe disease detected at birth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Training and consultancy
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In order to facilitate the transition to motherhood, theory-based training and counseling was provided to primiparous mothers on self and infant care.
|
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No Intervention: control group
Standard postpartum care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the level of difficulty in self-care of primipara mothers in post-cesarean (42 days)
Time Frame: 1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (post-cesarean 15th day) and 4th follow-up (post-cesarean 42nd day)
|
Change in the level of difficulty in self-care of primipara mothers in post-cesarean (42 days) was evaluated with a form prepared by the researchers using the literature.
This form consists of 15 Likert type items.
Each item is scored between 0 and 2. Therefore, the minimum score of the form is 0, while the maximum score of the form is 30.
If the score obtained from the form is high, the difficulty level is high, and if the score obtained from the form is low, the level of difficulty is low.
|
1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (post-cesarean 15th day) and 4th follow-up (post-cesarean 42nd day)
|
|
Change in the level of difficulty in baby-care of primipara mothers in post-cesarean (42 days)
Time Frame: 1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (postcesarean 15th day) and 4th follow-up (postcesarean 42nd day)
|
Change in the level of difficulty in baby-care of primipara mothers in post-cesarean (42 days) was evaluated with a form prepared by the researchers using the literature.
This form consists of 9 Likert type items.
Each item is scored between 0 and 2. Therefore, the minimum score of the form is 0, while the maximum score of the form is 18.
If the score obtained from the form is high, the difficulty level is high, and if the score obtained from the form is low, the level of difficulty is low.
|
1st follow-up (pre-training), 2nd follow-up (post-cesarean 5th day), 3rd follow-up (postcesarean 15th day) and 4th follow-up (postcesarean 42nd day)
|
|
Postpartum depression
Time Frame: Post-cesarean 42nd day
|
Edinburgh postpartum depression scale consists of 10 questions. The answers are evaluated in a 4-point Likert format and scored between 0-3. The total score of the scale is obtained by summing these item scores. Persons with a score above 12 points are considered a risk group. The lowest score is 0 and the highest score is 30. Primiparous mothers filled out the google form via whatsapp at the first interview (pre-training) and post-cesarean the 42nd day |
Post-cesarean 42nd day
|
|
Postpartum quality of life
Time Frame: Post-cesarean 42nd day
|
Postpartum quality of life scale is a likert-type scale consisting of five sub-dimensions and a total of 40 items.
Each item is evaluated for its importance and satisfaction for the mother.
The Quality of Life Score is in the range of 0-30.
Primiparous mothers filled out the google form via whatsapp at the first interview (pre-training) and post-cesarean the 42nd day
|
Post-cesarean 42nd day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayla KORKMAZ, Asst.Prof., Tokat Gaziosmanpasa University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20-KAEK-033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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