Congenital Heart DiseaseNCT04416230
Post-Op Massage in Infants With Congenital Heart Disease
A study testing massage and quiet time in people with Congenital Heart Disease, run by Ohio State University.
Trial summary
The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- massage and quiet time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 30 May 2014
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born with complex congenital heart disease requiring surgical intervention
- less than 12 months old
- undergoing first surgical procedure
Who cannot join
- on paralytics post-operatively
- cardiorespiratory instability
- on-going cardiac pacing
About this study
Official title: The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery
The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain.
Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively.
Read more
Specific Aim 2: To compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving.
Specific Aim 3: To examine potential moderators of pain response in the massage intervention group before and after receiving massage.
Read the detailed description
We used a two-group randomized clinical trial design with a sample of 60 infants with complex congenital heart disease (CCHD) between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group 1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
- Conditions
- Congenital Heart Disease
- Being tested
- massage, quiet time
- Keywords
- congenital heart disease, massage, pediatric pain
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
The massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back.
quiet timeBehavioural
During quiet time, the infant received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study. Receives: Behavioral: massage |
| Quiet Time | Active comparator | Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted. Receives: Behavioral: quiet time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Measured: Daily average for 7 days
Change in post-operative pain score with intervention
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Measured: Daily for 7 days
Heart rate
heart rate in beats per minute
Measured: Daily average for 7 days
Respiratory rate
respiratory rate in breaths per minute
Measured: Daily average for 7 days
Oxygen saturation
oxygen saturation percentage
Measured: Daily average for 7 days
Change in heart rate with intervention
heart rate in beats per minute
Measured: Daily for 7 days
Change in respiratory rate with intervention
respiratory rate in beats per minute
Measured: Daily for 7 days
Change in oxygen saturation with intervention
oxygen saturation percentage
Measured: Daily for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 May 2012
- Primary completion3 Aug 2013
- Study completion30 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- The intervention consisted of a massage given by a licensed massage therapist on each of seven consecutive days beginning on the day of surgery (Day 1). The massage included 30 minutes of Swedish massage on the infant's accessible upper extremities, lower extremities, head, face, and back. Standard precautions were used, including proper hand hygiene and the use of gloves when needed for infection control. Infants randomized to the comparison group received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Tondi Harrison, Ohio State University
- Investigators
- Tondi M Harrison, PhD, RN, Principal investigator, The Ohio State University and Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416230
- Sponsor's protocol ID
- IRB11-00662
- Status last verified
- Jun 2020
- First submitted
- 22 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
Blakely WP, Page GG. Pathophysiology of pain in critically ill patients. Crit Care Nurs Clin North Am. 2001 Jun;13(2):167-79. No abstract available.
PubMed 11866400Craig KD, Whitfield MF, Grunau RVE, Linton J, Hadjistavropoulos HD. Pain in the preterm neonate: behavioural and physiological indices. Pain. 1993 Mar;52(3):287-299. doi: 10.1016/0304-3959(93)90162-I.
PubMed 8460047Messerer B, Gutmann A, Weinberg A, Sandner-Kiesling A. Implementation of a standardized pain management in a pediatric surgery unit. Pediatr Surg Int. 2010 Sep;26(9):879-89. doi: 10.1007/s00383-010-2642-1. Epub 2010 Jul 13.
PubMed 20625751Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6.
PubMed 21048258Mitchinson AR, Kim HM, Rosenberg JM, Geisser M, Kirsh M, Cikrit D, Hinshaw DB. Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial. Arch Surg. 2007 Dec;142(12):1158-67; discussion 1167. doi: 10.1001/archsurg.142.12.1158.
PubMed 18086982Piotrowski MM, Paterson C, Mitchinson A, Kim HM, Kirsh M, Hinshaw DB. Massage as adjuvant therapy in the management of acute postoperative pain: a preliminary study in men. J Am Coll Surg. 2003 Dec;197(6):1037-46. doi: 10.1016/j.jamcollsurg.2003.07.020.
PubMed 14644293Nerbass FB, Feltrim MI, Souza SA, Ykeda DS, Lorenzi-Filho G. Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Clinics (Sao Paulo). 2010;65(11):1105-10. doi: 10.1590/s1807-59322010001100008.
PubMed 21243280Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
PubMed 20347836Albert NM, Gillinov AM, Lytle BW, Feng J, Cwynar R, Blackstone EH. A randomized trial of massage therapy after heart surgery. Heart Lung. 2009 Nov-Dec;38(6):480-90. doi: 10.1016/j.hrtlng.2009.03.001. Epub 2009 Jun 28.
PubMed 19944872Hernandez-Reif M, Field T, Largie S, Hart S, Redzepi M, Nierenberg B, Peck TM. Childrens' distress during burn treatment is reduced by massage therapy. J Burn Care Rehabil. 2001 Mar-Apr;22(2):191-5; discussion 190. doi: 10.1097/00004630-200103000-00021.
PubMed 11302609Field T, Hernandez-Reif M, Seligman S, Krasnegor J, Sunshine W, Rivas-Chacon R, Schanberg S, Kuhn C. Juvenile rheumatoid arthritis: benefits from massage therapy. J Pediatr Psychol. 1997 Oct;22(5):607-17. doi: 10.1093/jpepsy/22.5.607.
PubMed 9383925Benarroch EE. Pain-autonomic interactions. Neurol Sci. 2006 May;27 Suppl 2:S130-3. doi: 10.1007/s10072-006-0587-x.
PubMed 16688616Kirchner A, Birklein F, Stefan H, Handwerker HO. Left vagus nerve stimulation suppresses experimentally induced pain. Neurology. 2000 Oct 24;55(8):1167-71. doi: 10.1212/wnl.55.8.1167.
PubMed 11071495Kirchner A, Stefan H, Bastian K, Birklein F. Vagus nerve stimulation suppresses pain but has limited effects on neurogenic inflammation in humans. Eur J Pain. 2006 Jul;10(5):449-55. doi: 10.1016/j.ejpain.2005.06.005. Epub 2005 Aug 24.
PubMed 16125425Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
PubMed 16027695
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT04416230
- Acronym / sponsor ID
- IRB11-00662
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, massage, pediatric pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 May 2012 (actual)
- Primary completion
- 3 Aug 2013 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 4 Jun 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.
The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain.
Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively.
Specific Aim 2: To compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving.
Specific Aim 3: To examine potential moderators of pain response in the massage intervention group before and after receiving massage.
Detailed description
We used a two-group randomized clinical trial design with a sample of 60 infants with complex congenital heart disease (CCHD) between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group 1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention consisted of a massage given by a licensed massage therapist on each of seven consecutive days beginning on the day of surgery (Day 1). The massage included 30 minutes of Swedish massage on the infant's accessible upper extremities, lower extremities, head, face, and back. Standard precautions were used, including proper hand hygiene and the use of gloves when needed for infection control. Infants randomized to the comparison group received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Behavioral: massageInfants randomized to the massage intervention received a 30 minute massage daily for the 7 day study. |
| Quiet Time | Active comparator | Behavioral: quiet timeInfants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants born with complex congenital heart disease requiring surgical intervention
- less than 12 months old
- undergoing first surgical procedure
Key exclusion criteria (3 listed)
- on paralytics post-operatively
- cardiorespiratory instability
- on-going cardiac pacing
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 |
|---|---|---|
| massageThe massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back. | Behavioural | Massage |
| quiet timeDuring quiet time, the infant received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant. | Behavioural | Quiet Time |
Primary outcome
Post-operative pain score
Time frame: Daily average for 7 days
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Change in post-operative pain score with intervention
Time frame: Daily for 7 days
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Heart rate
Time frame: Daily average for 7 days
heart rate in beats per minute
Respiratory rate
Time frame: Daily average for 7 days
respiratory rate in breaths per minute
Oxygen saturation
Time frame: Daily average for 7 days
oxygen saturation percentage
Change in heart rate with intervention
Time frame: Daily for 7 days
heart rate in beats per minute
Change in respiratory rate with intervention
Time frame: Daily for 7 days
respiratory rate in beats per minute
Change in oxygen saturation with intervention
Time frame: Daily for 7 days
oxygen saturation percentage
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 4 Jun 2020.
- Background: PubMed 11866400Blakely WP, Page GG. Pathophysiology of pain in critically ill patients. Crit Care Nurs Clin North Am. 2001 Jun;13(2):167-79. No abstract available.
- Background: PubMed 8460047Craig KD, Whitfield MF, Grunau RVE, Linton J, Hadjistavropoulos HD. Pain in the preterm neonate: behavioural and physiological indices. Pain. 1993 Mar;52(3):287-299. doi: 10.1016/0304-3959(93)90162-I.
- Background: PubMed 20625751Messerer B, Gutmann A, Weinberg A, Sandner-Kiesling A. Implementation of a standardized pain management in a pediatric surgery unit. Pediatr Surg Int. 2010 Sep;26(9):879-89. doi: 10.1007/s00383-010-2642-1. Epub 2010 Jul 13.
- Background: PubMed 21048258Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6.
- Background: PubMed 18086982Mitchinson AR, Kim HM, Rosenberg JM, Geisser M, Kirsh M, Cikrit D, Hinshaw DB. Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial. Arch Surg. 2007 Dec;142(12):1158-67; discussion 1167. doi: 10.1001/archsurg.142.12.1158.
- Background: PubMed 14644293Piotrowski MM, Paterson C, Mitchinson A, Kim HM, Kirsh M, Hinshaw DB. Massage as adjuvant therapy in the management of acute postoperative pain: a preliminary study in men. J Am Coll Surg. 2003 Dec;197(6):1037-46. doi: 10.1016/j.jamcollsurg.2003.07.020.
- Background: PubMed 21243280Nerbass FB, Feltrim MI, Souza SA, Ykeda DS, Lorenzi-Filho G. Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Clinics (Sao Paulo). 2010;65(11):1105-10. doi: 10.1590/s1807-59322010001100008.
- Background: PubMed 20347836Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
- Background: PubMed 19944872Albert NM, Gillinov AM, Lytle BW, Feng J, Cwynar R, Blackstone EH. A randomized trial of massage therapy after heart surgery. Heart Lung. 2009 Nov-Dec;38(6):480-90. doi: 10.1016/j.hrtlng.2009.03.001. Epub 2009 Jun 28.
- Background: PubMed 11302609Hernandez-Reif M, Field T, Largie S, Hart S, Redzepi M, Nierenberg B, Peck TM. Childrens' distress during burn treatment is reduced by massage therapy. J Burn Care Rehabil. 2001 Mar-Apr;22(2):191-5; discussion 190. doi: 10.1097/00004630-200103000-00021.
- Background: PubMed 9383925Field T, Hernandez-Reif M, Seligman S, Krasnegor J, Sunshine W, Rivas-Chacon R, Schanberg S, Kuhn C. Juvenile rheumatoid arthritis: benefits from massage therapy. J Pediatr Psychol. 1997 Oct;22(5):607-17. doi: 10.1093/jpepsy/22.5.607.
- Background: PubMed 16688616Benarroch EE. Pain-autonomic interactions. Neurol Sci. 2006 May;27 Suppl 2:S130-3. doi: 10.1007/s10072-006-0587-x.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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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.
Tondi M Harrison, PhD, RN principal investigator
The Ohio State University and Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing massage and quiet time in people with Congenital Heart Disease, run by Ohio State University.
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 3 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 4 Jun 2020. 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?
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?
Post-operative pain score (time frame: Daily average for 7 days). The study lists 8 primary outcomes in all. 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 NCT04416230, which also lists 38 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 4 Jun 2020.