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Completed

NCT Number: NCT05533021

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

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.

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Key information

Conditions

Postpartum Care Behavior Behavioral Symptoms Cesarean Section Depression First Birth

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Collaborators

  • TC Erciyes University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 8, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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