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

NCT07470398 | Completed DMC

• 1 other identifier: UoK.CON.25.090
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Procedural Pain; Preterm Infants

Keywords

Gentle Touch Technique; Pain Level; Neonatal Intensive Care Unit; Respiratory Parameters; Painful Procedures

Outcome Measures

Primary Outcomes (4)

• Pain level

  Pain level will be assessed in preterm infants during painful procedures using the Neonatal Infant Pain Scale (NIPS). The NIPS ranges from 0 to 7, where higher scores indicate greater pain intensity. The scale evaluates facial expression, crying, breathing pattern, arm and leg movements, and state of arousal to determine the level of pain.

  Before the painful procedure, during the procedure, and immediately after the procedure

• Respiratory Rate

  Respiratory rate will be assessed in preterm infants during painful procedures by measuring the number of breaths per minute using standard neonatal monitoring devices available in the neonatal intensive care unit (NICU). The normal respiratory rate in preterm infants typically ranges from 40 to 60 breaths per minute. Changes in respiratory rate will be used as a physiological indicator of the infant's response to painful stimuli and to evaluate the potential calming effect of the gentle touch technique.

  Before the painful procedure, during the procedure, and immediately after the procedure.

• Oxygen Saturation (SpO2)

  Oxygen saturation (SpO₂) will be continuously monitored in preterm infants during painful procedures using pulse oximetry monitoring devices available in the neonatal intensive care unit (NICU). The normal oxygen saturation range for preterm infants typically ranges between 90% and 95%. Oxygen saturation levels will be used to assess physiological responses to pain and to evaluate the potential stabilizing effect of the gentle touch technique.

  Before the painful procedure, during the procedure, and immediately after the procedure.

• Skin Color

  Skin color changes will be observed in preterm infants during painful procedures as a clinical indicator of physiological responses to stress and pain. Normal skin color in preterm infants is typically pink, while abnormal findings may include pallor (paleness) or cyanosis (bluish discoloration), which may indicate physiological stress or instability. These observations will help evaluate the infant's response to painful stimuli and the potential soothing effect of the gentle touch technique.

  Before the painful procedure, during the procedure, and immediately after the procedure.

Study Arms (2)

Gentle Touch Group

EXPERIMENTAL

Participants in the Gentle Touch Group received the gentle touch technique during painful procedures. The researcher warmed her hands and gently placed one hand on the infant's head and the other hand on the abdomen while maintaining the infant in a supine position inside the incubator. The gentle touch technique was initiated before the painful procedure and continued during the procedure and for a short period after completion of the procedure. The total duration of the intervention ranged from 7 to 10 minutes. The intervention was performed by the researcher under the supervision of the neonatal intensive care unit nursing staff. Participants in the Control Group received routine neonatal care during the painful procedures without the application of the gentle touch technique. Pain levels were assessed using the Neonatal Infant Pain Scale (NIPS), and respiratory parameters including respiratory rate and oxygen saturation were measured before, during, and after the painful procedure

Other: Gentle Touch Technique

Control Group

NO INTERVENTION

Participants in the Control Group received routine neonatal care during painful procedures without applying the gentle touch technique.

Interventions

Gentle Touch Technique OTHER

The 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.

Gentle Touch Group

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a gestational age range from 28 to 36 weeks.
• Preterm infants admitted to the neonatal units of the selected teaching hospitals.
• Preterm infants who were clinically stable at the time of data collection.
• Preterm infants undergoing routine painful procedures as part of standard neonatal care.
• Preterm infants who did not receive analgesic or sedative medications prior to the procedure.
• Preterm infants whose parents or legal guardians agreed to participate in the study and provided informed consent.

You may not qualify if:

• Preterm infants with a gestational age of less than 28 weeks or more than 36 weeks.
• Preterm infants with congenital anomalies or genetic disorders.
• Preterm infants diagnosed with neurological impairment or central nervous system disorders.
• Preterm infants who were clinically unstable or required intensive medical interventions at the time of data collection.
• Preterm infants receiving analgesic or sedative medications prior to the painful procedures.
• Preterm infants with severe respiratory distress or requiring mechanical ventilation.
• Preterm infants who had undergone any painful procedure within 30 minutes prior to the study procedure.

Sponsors & Collaborators

• Karbala University: lead

Study Sites (3)

Al-Hindiya Teaching Hospital

Karbala, Kerbala, 56001, Iraq

Location

Karbala Teaching Hospital for Children

Karbala, Kerbala, 56001, Iraq

Location

Obstetrics and Gynecology Teaching Hospital

Karbala, Kerbala, 56001, Iraq

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruqaya M Jasim, BSc Nursing

  University of Kerbala, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's graduate student

Model Details: Participants in the Gentle Touch Group received the gentle touch technique during painful procedures. The researcher warmed her hands and gently placed one hand on the infant's head and the other hand on the abdomen while maintaining the infant in a supine position inside the incubator. The gentle touch technique was initiated before the painful procedure and continued during the procedure and for a short period after completion of the procedure. The total duration of the intervention ranged from 7 to 10 minutes. The intervention was performed by the researcher under the supervision of the neonatal intensive care unit nursing staff. Participants in the Control Group received routine neonatal care during the painful procedures without the application of the gentle touch technique. Pain levels were assessed using the Neonatal Infant Pain Scale (NIPS), and respiratory parameters including respiratory rate and oxygen saturation were measured before, during, and after the painful procedures

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (3)