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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Procedural Pain
• Intervention / Treatment: Other: Gentle Touch Technique

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kerbala
    • Karbala, Kerbala, Iraq, 56001
      • Al-Hindiya Teaching Hospital
    • Karbala, Kerbala, Iraq, 56001
      • Karbala Teaching Hospital for Children
    • Karbala, Kerbala, Iraq, 56001
      • Obstetrics and Gynecology Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gentle Touch Group; 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; 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.
No Intervention: Control Group; Participants in the Control Group received routine neonatal care during painful procedures without applying the gentle touch technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Karbala University
• Investigators: Principal Investigator: Ruqaya M Jasim, BSc Nursing, University of Kerbala, College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): January 31, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Neonatal Intensive Care Unit; Respiratory Parameters; Painful Procedures; Pain Level; Gentle Touch Technique
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural
• Other Study ID Numbers: UoK.CON.25.090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No