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NCT06348641
Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
NA trial testing baby massage in Pain in 60 participants. Not yet recruiting.
20 April 2025
Quick facts
| Lead sponsor | Nurgül Tekin |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 20 April 2024 |
| Primary completion | 20 April 2025 |
| Estimated completion | 20 April 2025 |
Drugs / interventions tested
- baby massage
Conditions studied
- Pain — all drugs for Pain →
- Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
- Premature Baby 26 to 32 Weeks — all drugs for Premature Baby 26 to 32 Weeks →
- Premature Baby 33 to 36 Weeks — all drugs for Premature Baby 33 to 36 Weeks →
Sponsor
Nurgül Tekin
Who can join
Adults 1 Day to 40 Days, any sex, with Pain or Retinopathy of Prematurity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist. The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant. The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06348641
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Pain
Currently open trials in the same condition.
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- NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
- NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting
Other Nurgül Tekin trials
Trials by the same sponsor.
- NCT06306794 — Reducing Pain Levels and Increasing Comfort of Premature Infants During Aspiration · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06348641 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nurgül Tekin
- Last refreshed: 5 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06348641.
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