Non Pharmacological Pain ManagementNCT06415240
Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates
A study testing Facilitated Tucking and Gentle Human Touch in people with Non Pharmacological Pain Management, run by Shifa Tameer-e-Millat University at 2 sites in Pakistan.
Trial summary
This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Non Pharmacological Pain Management
- What is being tested?
- Facilitated Tucking and Gentle Human Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 May 2024to 30 Nov 2024
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both term and preterm neonates.
- APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
- Admitted to the Neonatal Intensive Care Unit
- Undergoing arterial prick for the first time.
Who cannot join
- Documented birth asphyxia
- Congenital anomalies
- Neurological diagnosis,
- ventilated with paralysis
- Extremely premature newborns (Gestational age < 28 weeks)
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Pakistan Institute of Medical Sciences
Islamabad, 44000
Ayesha Majeed, MBBS, 92519107679 ext. 7679, info@szabmu.edu.pk
Subera Ahmad, BSN
- Not yet recruiting
Shifa Tameer E Millat University
Islamabad, 44000
Nazma Hamid, MSN, 03421547629, nazmahamid07@gmail.com
About this study
Official title: Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit
This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.
Read the detailed description
The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.
- Conditions
- Non Pharmacological Pain Management
- Being tested
- Facilitated Tucking, Gentle Human Touch
- Keywords
- Non Pharmacological Pain Management, Neonates, Procedural Pain
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated TuckingOther
Facilitated Tucking is a position to be adopted for pain relief in neonates.
Gentle Human TouchOther
while gentle human touch is caressing on head for pain relief.
| Study group | Role | What they receive |
|---|---|---|
| Facilitated Tucking | Experimental | A non pharmacological intervention to be implemented during arterial prick. Receives: Other: Facilitated Tucking |
| Gentle Human Touch | Experimental | A non pharmacological intervention to be implemented during arterial prick. Receives: Other: Gentle Human Touch |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale
scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome
Measured: Before,During Arterial Prick and after three minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start20 May 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Pharmacological Pain ManagementStudies 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
- Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazma Hamid, Shifa International Hospital
- Investigators
- Nazma Hamid, MSN, Principal investigator, Shifa Tameer E Millat Univesrity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415240
- Sponsor's protocol ID
- STMU
- Status last verified
- Aug 2024
- First submitted
- 10 May 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not intended
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Clinical Nurse Manager Working in Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06415240
- Acronym / sponsor ID
- STMU
- Conditions
- Non Pharmacological Pain Management
- Keywords
- Non Pharmacological Pain Management, Neonates, Procedural Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 May 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.
This is a Randomized Control Trial intended to investigate the effect of two non-pharmacological interventions on procedural pain among neonates.
Detailed description
The Study Design is a Randomized Control Trial, intended to investigate the effect of facilitated tucking and gentle human touch on procedural pain among neonates (age 28 days). Neonatal Infant Pain Scale will be used for pain scoring, data will be collected by recording demographic variables for all neonates and then capturing a video recording for pain scoring by an independent research assistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Facilitated Tucking | Experimental | Other: Facilitated TuckingA non pharmacological intervention to be implemented during arterial prick. |
| Gentle Human Touch | Experimental | Other: Gentle Human TouchA non pharmacological intervention to be implemented during arterial prick. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both term and preterm neonates.
- APGAR scores of a minimum of 6 at one minute and 8 at 5 minutes
- Admitted to the Neonatal Intensive Care Unit
- Undergoing arterial prick for the first time.
Key exclusion criteria (5 listed)
- Documented birth asphyxia
- Congenital anomalies
- Neurological diagnosis,
- ventilated with paralysis
- Extremely premature newborns (Gestational age < 28 weeks)
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 |
|---|---|---|
| Facilitated TuckingFacilitated Tucking is a position to be adopted for pain relief in neonates. | Other | Facilitated Tucking |
| Gentle Human Touchwhile gentle human touch is caressing on head for pain relief. | Other | Gentle Human Touch |
Primary outcome
Neonatal Infant Pain Scale
Time frame: Before,During Arterial Prick and after three minutes
scoring of pain based on a scale used in neonates both for term and pre term babies.( Minimum Pain Score 0, Maximum 7, Higher number indicates the worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No. Not intended
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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.
Nazma Hamid, MSN principal investigator
Shifa Tameer E Millat Univesrity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Tucking and Gentle Human Touch in people with Non Pharmacological Pain Management, run by Shifa Tameer-e-Millat University at 2 sites in Pakistan.
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 4 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazma Hamid, MSN (03421547629, nazmahamid07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (time frame: Before,During Arterial Prick and after three minutes). 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 20 Aug 2024.