Neonatal DisorderNCT04309162
Soft Tissue Therapy in Managing Procedural Pain Among Neonates.
A study testing Soft tissue therapy in people with Neonatal Disorder, run by Asir John Samuel at 1 site in India.
Trial summary
Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes various techniques like stroking, petrissage manipulations. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Soft tissue therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIndia
- Study dates
- 3 Aug 2020to 31 Mar 2021
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates who underwent various painful procedures in NICU such as venous, arterial and capillary puncture, mechanical ventilation for pulmonary causes, tracheal intubation, adhesive tapes removal, insertion of various drains etc.
- Preterm, Term, Post terms Neonates
- Stable Neonates.
Who cannot join
- Post-Surgical cases
- Parents of Neonates who are not willing to enroll their infant in study.
- Neonates with congenital anomalies.
- Neonates with extreme low birth weight.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Therapy in Managing Procedural Pain Among Neonates Admitted in Neonatal Intensive Care Unit: A Single Group, Pretest Posttest Quasi Experimental Study.
Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes various techniques like stroking, petrissage manipulations.
Read the detailed description
Background: Neonatal intensive care unit (NICU) is a specialized unit created for sick and premature newborns. There are various painful procedures through which neonates have to undergo during the NICU stay. The most common procedure is the blood tests for the laboratory investigations which include the heel lancing and venipuncture. Pain is the one of the cause of the development of the acute stress in neonates soft tissue therapy has considered as the major contributory factor of in reducing the procedural pain among neonates admitted NICU. There is no documentation on soft tissue therapy in managing procedural pain in neonates.
Purpose: To determine the effects of soft tissue therapy in managing procedural pain among neonates admitted in NICU.
Methods and materials: The study will recruit neonates who underwent for various painful procedures in NICU such as venous and arterial puncture, capillary puncture, pulmonary mechanical ventilation, tracheal intubation, removal of adhesive tapes, the introduction of various drains etc. Preterm, Term, Full terms Neonates Stable Neonates. The samples will be taken via stratified random sampling technique. Neonates with unstable vitals are to be excluded from the study.
Discussion: To best of our knowledge, this will be the first study determining the effects of soft tissue therapy in procedural pain on neonates admitted in NICU. The role of neonatal physiotherapist in NICU is to provide diagnosis and treatment to admitted newborns. Massage therapy is considered as an effective management technique in pain management. In this study soft tissue therapy will be applied to neonates especially in context with procedural pain. There are various painful procedures performed to check the prognosis of neonates.
Keywords: Neonatal; Newborns; Infant; NICU; Procedural pain; Massage therapy.
- Conditions
- Neonatal Disorder
- Being tested
- Soft tissue therapy
- Keywords
- Neonatal, Newborns, Infant, NICU, Procedural Pain, Massage Therapy
- Medical subject headings
- Infant, Newborn, Diseases, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue therapyOther
Soft tissue therapy consists of various soft tissue manipulating techniques which includes the stroking, percussive and tapping manipulations. The treatment techniques are divided according to the body parts. under this techniques are tapping, flat finger kneading, Stroking, skin rolling etc.
| Study group | Role | What they receive |
|---|---|---|
| soft tissue therapy | Experimental | Soft tissue therapy includes various techniques which is usually done by manipulating the soft tissues. The techques like stroking, petrissage, percussing maniulations are proved helpful in managing various painful conditions. The main effect of the soft tissue therapy is enhanced blood circulation to the area. When the techniques of soft tissue therapy are applied they will results in stretching and rubbing the muscular tissue which results in increased venous flow to heart and removal of the lactic acid accumulation occurs as the fresh supply of blood to the area will increased. Endorphins the natural pain relievers are released as there is improved oxygenation and perfusion of oxygen in tissues. Receives: Other: Soft tissue therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neonatal Infant Pain Scale (NIPS)
Neonatal Infant Pain Scale is basically a behavioral tool and can be used in preterm and full term infants. The total score is 7. NIPS score is divided into 3 categories. 0-2 indicates no pain, 3-4 mild to moderate pain, >4 indicates severe pain.
Measured: Baseline, 4 days after the intervention.
Secondary outcomes (1)
Change in Neonatal Pain Agitation and sedation scale(N-PASS)
N-PASS is scale which is used to assess Procedural, postoperative mechanically . ventilated patients. It includes variables like crying, irritability, facial expression, extremity tone and vital signs. It is 0 to 10 scale high level of score indicates more aggression and intense behavior and low levels indicates decreased level of stimulation and deeper sedation.
Measured: Baseline, 4 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start3 Aug 2020
- Primary completion26 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single group Pretest-Posttest quasi experimental design
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Abhishek Sharma, BPT, Principal investigator, Maharishi Markandeshwar institute of Physiotherapy and RehabilitationAsir J Samuel, MPT, PhD, Study chair, Maharishi Markandeshwar institute of Physiotherapy and RehabilitationNeha Sharma, MPT, Study director, Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309162
- Sponsor's protocol ID
- MMDU/IEC/1528
- Other IDs
- U1111-1249-2317
- Status last verified
- Apr 2021
- First submitted
- 6 Mar 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
PubMed 22374882Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
PubMed 28368368Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.
PubMed 20137814Jain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.
PubMed 16925535
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Therapy in Managing Procedural Pain Among Neonates Admitted in Neonatal Intensive Care Unit: A Single Group, Pretest Posttest Quasi Experimental Study.
- ClinicalTrials.gov ID
- NCT04309162
- Acronym / sponsor ID
- MMDU/IEC/1528
- Conditions
- Neonatal Disorder
- Keywords
- Neonatal, Newborns, Infant, NICU, Procedural Pain, Massage Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 16 Mar 2020 (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.
Effect of Soft tissue Therapy in managing Procedural Pain among neonates admitted in neonatal intensive care unit. This study focuses on the Procedural pain management with the help of Soft tissue manipulation which includes various techniques like stroking, petrissage manipulations.
Detailed description
Background: Neonatal intensive care unit (NICU) is a specialized unit created for sick and premature newborns. There are various painful procedures through which neonates have to undergo during the NICU stay. The most common procedure is the blood tests for the laboratory investigations which include the heel lancing and venipuncture. Pain is the one of the cause of the development of the acute stress in neonates soft tissue therapy has considered as the major contributory factor of in reducing the procedural pain among neonates admitted NICU. There is no documentation on soft tissue therapy in managing procedural pain in neonates.
Purpose: To determine the effects of soft tissue therapy in managing procedural pain among neonates admitted in NICU.
Methods and materials: The study will recruit neonates who underwent for various painful procedures in NICU such as venous and arterial puncture, capillary puncture, pulmonary mechanical ventilation, tracheal intubation, removal of adhesive tapes, the introduction of various drains etc. Preterm, Term, Full terms Neonates Stable Neonates. The samples will be taken via stratified random sampling technique. Neonates with unstable vitals are to be excluded from the study.
Discussion: To best of our knowledge, this will be the first study determining the effects of soft tissue therapy in procedural pain on neonates admitted in NICU. The role of neonatal physiotherapist in NICU is to provide diagnosis and treatment to admitted newborns. Massage therapy is considered as an effective management technique in pain management. In this study soft tissue therapy will be applied to neonates especially in context with procedural pain. There are various painful procedures performed to check the prognosis of neonates.
Keywords: Neonatal; Newborns; Infant; NICU; Procedural pain; Massage therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group Pretest-Posttest quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| soft tissue therapy | Experimental | Other: Soft tissue therapySoft tissue therapy includes various techniques which is usually done by manipulating the soft tissues. The techques like stroking, petrissage, percussing maniulations are proved helpful in managing various painful conditions. The main effect of the soft tissue therapy is enhanced blood circulation to the area. When the techniques of soft tissue therapy are applied they will results in stretching and rubbing the muscular tissue which results in increased venous flow to heart and removal of the lactic acid accumulation occurs as the fresh supply of blood to the area will increased. Endorphins the natural pain relievers are released as there is improved oxygenation and perfusion of oxygen in tissues. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates who underwent various painful procedures in NICU such as venous, arterial and capillary puncture, mechanical ventilation for pulmonary causes, tracheal intubation, adhesive tapes removal, insertion of various drains etc.
- Preterm, Term, Post terms Neonates
- Stable Neonates.
Key exclusion criteria (4 listed)
- Post-Surgical cases
- Parents of Neonates who are not willing to enroll their infant in study.
- Neonates with congenital anomalies.
- Neonates with extreme low birth weight.
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 |
|---|---|---|
| Soft tissue therapySoft tissue therapy consists of various soft tissue manipulating techniques which includes the stroking, percussive and tapping manipulations. The treatment techniques are divided according to the body parts. under this techniques are tapping, flat finger kneading, Stroking, skin rolling etc. | Other | soft tissue therapy |
Primary outcome
Change in Neonatal Infant Pain Scale (NIPS)
Time frame: Baseline, 4 days after the intervention.
Neonatal Infant Pain Scale is basically a behavioral tool and can be used in preterm and full term infants. The total score is 7. NIPS score is divided into 3 categories. 0-2 indicates no pain, 3-4 mild to moderate pain, >4 indicates severe pain.
1 secondary outcome
Change in Neonatal Pain Agitation and sedation scale(N-PASS)
Time frame: Baseline, 4 days after the intervention
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 Apr 2021.
- Results publication: PubMed 22374882Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
- Results publication: PubMed 28368368Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
- Results publication: PubMed 20137814Field T, Diego M, Hernandez-Reif M. Preterm infant massage therapy research: a review. Infant Behav Dev. 2010 Apr;33(2):115-24. doi: 10.1016/j.infbeh.2009.12.004.
- Results publication: PubMed 16925535Jain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.
- Preterm infants are exposed to various painful procedures in Neonatal intensive care unit. Early Procedural pain exposure results int the harmful effects on the development of brain.Link provided by the sponsor.
- randomized controlled trials on the effects of massage in preterm infants suggest improved weight gain and shortened length of hospital stay. Improved weight gain may be mediated through increase in vagal tone but more studies are needed.Link provided by the sponsor.
- Massage therapy is considered as the effective non pharmacological measure for reducing the procedural pain in NICU and reduces their hospital stay.Link provided by the sponsor.
- By applying massage therapy before doing heel stick procedure pain responses are reduced in preterm infantsLink provided by the sponsor.
- 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.
Abhishek Sharma, BPT principal investigator
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Asir J Samuel, MPT, PhD study chair
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Neha Sharma, MPT study director
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue therapy in people with Neonatal Disorder, run by Asir John Samuel at 1 site in India.
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 3 inclusion and 4 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Change in Neonatal Infant Pain Scale (NIPS) (time frame: Baseline, 4 days after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309162, which also lists 4 linked publications.
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 Apr 2021.