UnknownNot Applicable

The Impact of Back and Breast Massage

Turkey (Türkiye)60 participantsStarted 2021-08-06

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for the research are as follows: * Having a caesarean or vaginal delivery for the first time, * Giving preterm birth between 32-37 weeks, * Having only one baby, * Having a baby with an APGAR score above 4, * Having the baby in the intensive care unit or being apart from the baby, * Not having any psychiatric disease, * Being aged 18 and over and having no communication problems such as seeing, hearing or speaking. Exclusion criteria from the research are as follows; * Having a mental and psychological disorder, * being HIV-infected * Having a breast surgery before, or having a history of breast cancer, * Having breast infection, * Living apart from the husband or being divorced, * Having lost the baby.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amount of Milk

Timeframe: Change from Amount of Milk 7 Days

Level of Anxiety

Timeframe: 1th day

Level of Anxiety

Timeframe: 7th day

Level of Anxiety

Timeframe: 6th week

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day

Trial details

NCT IDNCT04980053

SponsorSeyma Kilci Erciyas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-10

Contact for this trial

Şeyma K ERCİYAS

5454720162 seymakilcisk@gmail.com

View on ClinicalTrials.gov More Premature Birth trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Amount of Milk

Timeframe: Change from Amount of Milk 7 Days

Level of Anxiety

Timeframe: 1th day

Level of Anxiety

Timeframe: 7th day

Level of Anxiety

Timeframe: 6th week

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day

Socio-demographic characteristics of participant

Timeframe: 1th day