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NCT Number: NCT07470398

Effectiveness of Gentle Touch Technique on Pain Level 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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Preterm Infants Signs and Symptoms

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Hindiya Teaching Hospital, Karbala, Kerbala, Iraq

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain level

    Time frame: Before the painful procedure, during the procedure, and immediately after the procedure

    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.

  2. Respiratory Rate

    Time frame: Before the painful procedure, during the procedure, and immediately after the procedure.

    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.

  3. Oxygen Saturation (SpO2)

    Time frame: Before the painful procedure, during the procedure, and immediately after the procedure.

    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.

  4. Skin Color

    Time frame: Before the painful procedure, during the procedure, and immediately after the procedure.

    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.

Sponsors and collaborators

Lead sponsor

Karbala University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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