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The Impact of Back and Breast Massage

NCT04980053 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-05

No results posted yet for this study

Summary

In the study, selections to the experimental and control groups will be made randomly and simple randomization method will be used. In this context, the individuals included in the research will be assigned to the control and initiative groups respectively and randomized by an expert statistician.The sample of the study was found to be at the 95% confidence interval and at the level of α= 0.05. The effect size was found to be 0.5703 based on previous studies. With a theoretical power of 0.95, the minimum sample size was totally calculated as 51, 17 for the intervention 1 (back massage), 17 for the intervention 2 (breast massage) group and 17 for the control group. However, it was aimed to reach 60 people by predicting that there might be case losses, and it was planned to recruit 20 people for each group.

The dependent variables of the study are the amount of breast milk and the level of anxiety. The independent variable is the back and breast massage practice.

This research will be carried out in Zonguldak Gynecology and Pediatrics Hospital between 1st July 2021-2022.

Conditions

  • Premature Birth

Interventions

OTHER

massage

Intervention group Control group

Sponsors & Collaborators

  • Seyma Kilci Erciyas

    lead OTHER

Principal Investigators

  • Şeyma K ERCİYAS · Ege University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2022-03-10
Completion
2022-06-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980053 on ClinicalTrials.gov