PainNCT06348641
Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination
A study testing baby massage in people with Pain and Retinopathy of Prematurity, run by Nurgül Tekin.
Trial summary
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. Read more about this study
- Who is it for?
- Ages 1 day to 40 days
- Conditions the study is for
- Pain, Retinopathy of Prematurity, Premature Baby 26 to 32 Weeks
- What is being tested?
- baby massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 20 Apr 2025
- 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 1 day to 40 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <32 gestational age
- Birth weight of <1500g
- Who were clinical stable
- Baby's first eye examination
- The baby's family has permission
Who cannot join
- Infants with previous ROP examination
- Lack of mechanical ventilator support
- Major congenital anomaly
- Intraventriculer bleeding
- Receiving analgesic medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Massage Applied Before The Retinopathy of Prematurity Examination on the Pain Level and Comfort of the Newborn
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.
This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
Read more
Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.
The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
- Conditions
- Pain, Retinopathy of Prematurity, Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks
- Being tested
- baby massage
- Medical subject headings
- Pain, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baby massageOther
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Babies in intervention classes will receive baby massage before the examination. Pre-examination baby massage will be applied by a single nurse = researcher. Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher.
Babies will be massaged by the researcher in accordance with IAIM rules and massage techniques. The total massage time will be equal for each baby. Receives: Other: baby massage |
| control group | No intervention | For the control group, the routine retinopathy examination of the unit will be performed without any intervention. Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during examination for retinopathy of prematurity
Reducing the premature baby pain scale score of the experimental group compared to the control group.
It is suitable for term and preterm babies and is used to evaluate acute and procedural pain. Scoring ranges from 0 to 21, with a score of six or lower being considered as no or minimal pain, between 7-12 points as moderate pain, and between 13-21 points as severe pain. It is evaluated 15 seconds before the intervention and 30 seconds after the intervention.
Measured: Before, during and after ROP examination
Secondary outcomes (1)
Comfort during retinopathy of prematurity examination
Reducing the premature baby comfort scale score of the experimental group compared to the control group.
It is a multidimensional scale used to evaluate behavioral and psychological comfort and pain. Premature baby comfort scale evaluates 7 parameters such as Alertness, Calm/Agitation, Respiratory Status (only in mechanical ventilation support) or Crying (not evaluated because it is scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5, from worst to best.
According to the scale, 35 indicates the lowest and 7 indicates the highest comfort score. A high score from the scale indicates that the comfort level is low. If the total score obtained is ≥17, it is the cut-off value of the scale, it is the limit value for the baby's comfort level and indicates the need for a pain-reducing intervention.
Measured: Before, during and after ROP examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion20 Apr 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurgül Tekin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurgül Tekin, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348641
- Sponsor's protocol ID
- 2011-KAEK-25 2022/12-11
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage Applied Before The Retinopathy of Prematurity Examination on the Pain Level and Comfort of the Newborn
- ClinicalTrials.gov ID
- NCT06348641
- Acronym / sponsor ID
- 2011-KAEK-25 2022/12-11
- Conditions
- Pain, Retinopathy of Prematurity, Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nurgül TekinUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 5 Apr 2024 (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.
The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn.
This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist.
The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher.
Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant.
The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: baby massageBabies in intervention classes will receive baby massage before the examination. Pre-examination baby massage will be applied by a single nurse = researcher. Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher. Babies will be massaged by the researcher in accordance with IAIM rules and massage techniques. The total massage time will be equal for each baby. |
| control group | No intervention | –For the control group, the routine retinopathy examination of the unit will be performed without any intervention. Video recording will be taken before and during the ROP examination, and evaluations will be made by two neonatal nurses other than the researcher. |
Who may qualify
- Ages
- 1 day to 40 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- <32 gestational age
- Birth weight of <1500g
- Who were clinical stable
- Baby's first eye examination
- The baby's family has permission
Key exclusion criteria (5 listed)
- Infants with previous ROP examination
- Lack of mechanical ventilator support
- Major congenital anomaly
- Intraventriculer bleeding
- Receiving analgesic medication
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 |
|---|---|---|
| baby massageThe infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. | Other | experimental group |
Primary outcome
Pain during examination for retinopathy of prematurity
Time frame: Before, during and after ROP examination
Reducing the premature baby pain scale score of the experimental group compared to the control group. It is suitable for term and preterm babies and is used to evaluate acute and procedural pain. Scoring ranges from 0 to 21, with a score of six or lower being considered as no or minimal pain, between 7-12 points as moderate pain, and between 13-21 points as severe pain. It is evaluated 15 seconds before the intervention and 30 seconds after the intervention.
1 secondary outcome
Comfort during retinopathy of prematurity examination
Time frame: Before, during and after ROP examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing baby massage in people with Pain and Retinopathy of Prematurity, run by Nurgül Tekin.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurgül TEKIN (0224 295 50 00 ext. 3311, nurgulkrtls@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during examination for retinopathy of prematurity (time frame: Before, during and after ROP examination). 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 5 Apr 2024.