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

NCT05533021 | Completed DMC

• 1 other identifier: 20-KAEK-033
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Care; First Birth; Cesarean Section

Keywords

Depression; Difficulty; Meleis's Transition Theory; Postpartum Period; Primipara Mother; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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

• 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

Study Arms (2)

intervention group

EXPERIMENTAL

Training and consultancy

Other: Training and Consultancy

control group

NO INTERVENTION

Standard postpartum care

Interventions

Training and Consultancy OTHER

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: focused on postpartum mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• TC Erciyes University: collaborator

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ayla KORKMAZ, Asst.Prof.

  Tokat Gaziosmanpasa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized controlled experimental study

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 8, 2022
• Study Start: July 15, 2020
• Primary Completion: April 15, 2021
• Study Completion: January 28, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)