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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05533021
Other study ID # 20-KAEK-033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date January 28, 2022

Study information

Verified date September 2022
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The randomized controlled experimental study sought to determine the impact of the training structured according to Meleis's Transition Theory on postpartum difficulties and quality of life in primipara mothers.


Description:

In the study, the intervention group (39 mothers) was given face-to-face training in the hospital, which was structured according to Meleis' Transition theory, 24 hours after the cesarean section.Telephone counseling was provided on the 5th, 15th and 42nd days after discharge. Thus, these mothers were followed up 4 times in the postpartum period. No intervention was made in the control group (40 mothers).


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date January 28, 2022
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Training and Consultancy
In order to facilitate the transition to motherhood, theory-based training and counseling was provided to primiparous mothers on self and infant care.

Locations

Country Name City State
Turkey Tokat Gaziosmanpasa University Tokat

Sponsors (2)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the level of difficulty in self-care of primipara mothers in post-cesarean (42 days) 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)
Primary Change in the level of difficulty in baby-care of primipara mothers in post-cesarean (42 days) 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)
Primary Postpartum depression 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
Primary Postpartum quality of life 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
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