CompletedNot Applicable

Effect of Reflexology on Pain Management in Newborns

Turkey (Türkiye)300 participantsStarted 2019-12-01

Plain-language summary

Introduction: Approximately 10-14 painful procedures per day are performed in preterm and term infants during the hospital stay in the first week. The investigators aimed to determine the effect of reflexology being applied to the sole during painful procedures on pain perception, behavioral responses, and physiological changes in newborns compared with other non-pharmacological methods. Material and Method: This study was planned as a randomized controlled trial in term infants being followed up in the Neonatal Intensive Care Unit (NICU) and maternity ward. To reduce pain during attempts to collect venous blood or heel lance which are routinely applied to term newborns before discharge; reflexology on the soles of the foot, 24% sucrose solution, kangaroo care, listening to classical music were applied to the babies and were compared to those who did not have any analgesic method.

Who can participate

Age range

2 Days – 28 Days

Sex

ALL

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: * Newborns who are hospitalized in the NICU and maternity ward who will undergo heel lance or venous blood sampling before discharge. * Those who meet the discharge criteria recommended in the TNS guideline * Approved family informed consent. Exclusion Criteria: * Infants born with a birth weight below 2500 g and over 4000 g * Infants born before 37 gestational weeks, * Presence of major congenital anomaly or neurological problems.

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

Effect of Reflexology on change in pain perception during painful procedures in Newborns

Timeframe: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

Effect of Reflexology on crying time during painful procedures in Newborns

Timeframe: from beginning of the painful intervention until crying stops measured in minutes

Effect of Reflexology on change in blood pressure during painful procedures in Newborns

Timeframe: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

Effect of Reflexology on change in oxygen saturation during painful procedures in Newborns

Timeframe: 2 minutes before (pre-intervention), at the beginning of the intervention, and 2 minutes after (immediately after the intervention) the painful interventions

Trial details

NCT IDNCT05235893

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-30

View on ClinicalTrials.gov More Pain, Procedural trials