Clinical Trials Directory

Trials / Completed

CompletedNCT07470398

Effectiveness of Gentle Touch Technique on Pain Level During Painful Procedures in Preterm Infants

Effectiveness of Gentle Touch Technique on Pain Level and Respiratory Parameters During Painful Procedures in Preterm Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Karbala University · Academic / Other
Sex
All
Age
0 Days – 30 Days
Healthy volunteers
Not accepted

Summary

Preterm infants in neonatal intensive care units frequently undergo painful procedures that may affect their physiological stability, including pain level and respiratory parameters. Non-pharmacological interventions such as gentle touch technique are considered safe and effective methods for reducing pain in premature infants. This study aims to evaluate the effectiveness of gentle touch technique on pain level and respiratory parameters during painful procedures in preterm infants admitted to neonatal intensive care units in Karbala teaching hospitals. The study will compare infants receiving gentle touch intervention with those receiving routine care to determine its effect on reducing pain and improving respiratory stability.

Detailed description

Painful procedures are common among preterm infants admitted to neonatal intensive care units. These procedures may lead to physiological instability and increased stress responses. Non-pharmacological methods such as gentle touch technique have been suggested as effective and safe interventions to reduce pain and improve physiological outcomes. This experimental study will be conducted among preterm infants admitted to neonatal intensive care units in Karbala teaching hospitals. A sample of premature infants will be selected using convenience sampling. The infants will be randomly assigned to the intervention and control groups using a simple random sampling method (lottery method) to minimize selection bias. One group will receive the gentle touch technique during painful procedures while the other group will receive routine care. Pain level will be assessed using an appropriate neonatal pain assessment tool, and respiratory parameters such as respiratory rate and oxygen saturation will be measured. The study aims to determine whether gentle touch technique can significantly reduce pain and stabilize respiratory parameters among premature infants during painful procedures.

Conditions

Interventions

TypeNameDescription
OTHERGentle Touch TechniqueThe gentle touch technique was applied to preterm infants during painful procedures. A total of 60 preterm infants participated in the study. Thirty infants were assigned to the intervention group and received the gentle touch technique, while the other thirty infants were assigned to the control group and received routine neonatal care without the gentle touch intervention. The researcher gently placed one hand on the infant's head and the other hand on the abdomen while the infant remained in a supine position inside the incubator. The intervention started before the painful procedure and continued during and shortly after the procedure. The total duration of the intervention ranged from 7 to 10 minutes. The procedure was performed by the researcher under the supervision of neonatal intensive care unit nurses.

Timeline

Start date
2025-09-01
Primary completion
2026-01-31
Completion
2026-01-31
First posted
2026-03-13
Last updated
2026-03-13

Locations

3 sites across 1 country: Iraq

Source: ClinicalTrials.gov record NCT07470398. Inclusion in this directory is not an endorsement.