Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers

Cesarean Section Clinical Trial

Official title:

Impact of the Training Structured According to Meleis's Transition Theory on Postpartum Difficulties and Quality of Life in Primipara Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533021
• Other study ID #: 20-KAEK-033
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cesarean Section
• First Birth
• Postpartum Care

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