Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue

NCT06505733 | Not Yet Recruiting

• 1 other identifier: KaratayU-EBE-HA-01
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, it is aimed to investigate the effect of the trainings included in the content of the practical guide for postpartum supporter training companions, which will be given to the companions of women in the postpartum period, on depression and fatigue on mothers. The research will be conducted in methodological and single blind randomised control design. The study will be conducted at Necmettin Erbakan University Faculty of Medicine Hospital. A total of 70 puerperants will be included in the study as intervention (n: 35) and control (n: 35) groups. Introductory Information Form, Postpartum depression rating scale as data collection tools in the study: Motherhood Monitoring Scale by Parents (MMSP), Edinburgh Postnatal Depression Scale (EDDS), Multidimensional Fatigue Rating Scale will be used. The research data will be collected three times as pre-test data, fourth day and tenth day. Number, percentage, mean and standard deviation will be used in the evaluation of descriptive data; Chi-square test will be used for the similarity of the descriptive characteristics of the experimental and control groups; Kolmogrow-Smirnov and Shapiro-Wilk will be used in the normality analysis of dependent variables; t test in independent groups (student t test) will be used to compare the post-test scores of the experimental and control groups; and ANOVA in dependent groups will be used to compare the pre-test-post-test mean scores of the experimental group and eta square will be used to calculate effect sizes. The results obtained will be tested at p\<0.05 significance level and bidirectionally. When the literature is examined, there is not enough data on the depression and fatigue of the companion caring for the woman in the postpartum period. This study aims to fill the gaps in the literature and to reduce depression and fatigue in mothers.

Conditions

Postpartum; Fatigue; Depression; Social Support

Keywords

social support; Depression; Fatigue; Postpartum

Outcome Measures

Primary Outcomes (1)

• change in the depression level of the companion on the 10th day of the postnatal period compared to the baseline value

  The EPDS is a self-report scale consisting of 10 items in a 4-point Likert format. The responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 30. As the score increases, the level of depression increases. " Parent Rating Scale for Postpartum Depression: Maternity Monitoring Scale by Parents" , approval was received from the author after the translation of the scale questions.

  0-10 day

Secondary Outcomes (1)

• change in the fatigue level of the attendant on the 10th day of the postnatal period compared to the baseline value

  0-10 day

Study Arms (2)

attendants in the postnatal period

EXPERIMENTAL

In the guide, the needs of the postpartum mother and baby, postpartum depression (definition, symptoms, risk factors, complications, care), the role and responsibilities of the companion in supporting the postpartum mother are included.

Behavioral: postnatal attendant training

non-intervention group

NO INTERVENTION

the group will not be trained

Interventions

postnatal attendant training BEHAVIORAL

Intervention Group: Training and counselling will be provided to the puerperant and companions before discharge in a quiet and stimulus-free environment using the "Companion Training Guide". Research data will be collected three times: pre-test data, after the training and on the tenth day.

Also known as: pre-test data, post-training and tenth day

attendants in the postnatal period

Eligibility Criteria

• Gender Eligibility Details: mother or mother-in-law of women in the postnatal period
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Knowing how to read and write Turkish,
• Volunteer to participate in the research,
• She gave birth by cesarean section,
• Primiparous,
• Pregnant women who are open to communication (able to understand and answer questions) will be included in the sample.

You may not qualify if:

• Those who do not have the skills of reading, listening, writing, speaking and understanding Turkish,
• Those who have a hearing or visual impairment,
• Having postpartum complications,
• giving birth to stillbirth,
• People who wanted to withdraw from the study were not included.

Sponsors & Collaborators

• KTO Karatay University: lead

MeSH Terms

Conditions

Fatigue; Depression

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Hediye Ass. Prof. Karakoç, assistant professor

  KTO Karatay Univeristy

  STUDY DIRECTOR

Central Study Contacts

HURİYE M.Sc. ALTINKAYNAK, degree

CONTACT

05511485563; asaltinkaynak@hotmail.com

Hediye Ass.Prof. Karakoç, assistant professor

CONTACT

05412291726; hediye.bekmezci@karatay.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded in the study. The researcher will not be blinded because he/she is the implementer. However, the researcher will open the envelope created by the statistician just before the application and learn which group the mother is in. In order to prevent bias in the evaluation of the data, the groups will be coded as A and B, and the data will be analysed by an independent statistician. After the analysis and interpretation of the data is completed, the codes of the intervention and control groups will be revealed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Researcher

Model Details: group who received companion training, group who did not receive training

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: August 7, 2024
• Primary Completion: August 7, 2024
• Study Completion: August 17, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 7 August 2024-25 May 2025