Procedural PainNCT07470398
Effectiveness of Gentle Touch Technique on Pain Level During Painful Procedures in Preterm Infants
A study testing Gentle Touch Technique in people with Procedural Pain and Preterm Infants, run by Karbala University at 3 sites in Iraq.
Trial summary
Preterm infants in neonatal intensive care units frequently undergo painful procedures that may affect their physiological stability, including pain level and respiratory parameters. Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Procedural Pain, Preterm Infants
- What is being tested?
- Gentle Touch Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesIraq
- Study dates
- 1 Sep 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Iraq3 sites
Al-Hindiya Teaching Hospital
Karbala, Kerbala, 56001
Karbala Teaching Hospital for Children
Karbala, Kerbala, 56001
Obstetrics and Gynecology Teaching Hospital
Karbala, Kerbala, 56001
About this study
Official title: 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.
Read the 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
- Procedural Pain, Preterm Infants
- Being tested
- Gentle Touch Technique
- Keywords
- Gentle Touch Technique, Pain Level, Neonatal Intensive Care Unit, Respiratory Parameters, Painful Procedures
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Touch TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the painful procedure, during the procedure, and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Sep 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karbala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruqaya Mohammed Jasim, Ministry of Health, Iraq
- Investigators
- Ruqaya M Jasim, BSc Nursing, Principal investigator, University of Kerbala, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470398
- Sponsor's protocol ID
- UoK.CON.25.090
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gentle Touch Technique on Pain Level and Respiratory Parameters During Painful Procedures in Preterm Infants
- ClinicalTrials.gov ID
- NCT07470398
- Acronym / sponsor ID
- UoK.CON.25.090
- Conditions
- Procedural Pain, Preterm Infants
- Keywords
- Gentle Touch Technique, Pain Level, Neonatal Intensive Care Unit, Respiratory Parameters, Painful Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karbala UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Gentle Touch Group | Experimental | Other: Gentle Touch TechniqueParticipants 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 |
| Control Group | No intervention | –Participants in the Control Group received routine neonatal care during painful procedures without applying the gentle touch technique. |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle 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. | Other | Gentle Touch Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruqaya M Jasim, BSc Nursing principal investigator
University of Kerbala, College of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Touch Technique in people with Procedural Pain and Preterm Infants, run by Karbala University at 3 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Before the painful procedure, during the procedure, and immediately after the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.