Post-Op Massage in Infants With Congenital Heart Disease
NCT ID: NCT04416230
Last Updated: 2020-06-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
65 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-05-01
Study Completion Date
2014-05-30
Brief Summary
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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.
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.
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Detailed Description
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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
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Congenital Heart Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Caregivers
Outcome Assessors
Research assistants scoring participant pain were blinded to group.
Study Groups
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Massage
Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.
Group Type
EXPERIMENTAL
massage
Intervention Type
BEHAVIORAL
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 Time
Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.
Group Type
ACTIVE_COMPARATOR
quiet time
Intervention Type
BEHAVIORAL
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.
Interventions
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massage
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.
Intervention Type
BEHAVIORAL
quiet time
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Infants born with complex congenital heart disease requiring surgical intervention
* less than 12 months old
* undergoing first surgical procedure
* less than 12 months old
* undergoing first surgical procedure
Exclusion Criteria
* on paralytics post-operatively
* cardiorespiratory instability
* on-going cardiac pacing
* cardiorespiratory instability
* on-going cardiac pacing
Minimum Eligible Age
1 Day
Maximum Eligible Age
12 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Nationwide Children's Hospital
OTHER
Sponsor Role
collaborator
Ohio State University
OTHER
Sponsor Role
lead
Responsible Party
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Tondi Harrison
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tondi M Harrison, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University and Nationwide Children's Hospital
References
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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.
Reference Type
BACKGROUND
Craig 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.
Reference Type
BACKGROUND
Messerer 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.
Reference Type
BACKGROUND
Kulkarni 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.
Reference Type
BACKGROUND
Mitchinson 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.
Reference Type
BACKGROUND
Piotrowski 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.
Reference Type
BACKGROUND
Nerbass 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.
Reference Type
BACKGROUND
Bauer 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.
Reference Type
BACKGROUND
Albert 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.
Reference Type
BACKGROUND
Hernandez-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.
Reference Type
BACKGROUND
Field 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.
Reference Type
BACKGROUND
Benarroch EE. Pain-autonomic interactions. Neurol Sci. 2006 May;27 Suppl 2:S130-3. doi: 10.1007/s10072-006-0587-x.
Reference Type
BACKGROUND
Kirchner 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.
Reference Type
BACKGROUND
Kirchner 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.
Reference Type
BACKGROUND
Diego 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.
Reference Type
BACKGROUND
McCain GC, Ludington-Hoe SM, Swinth JY, Hadeed AJ. Heart rate variability responses of a preterm infant to kangaroo care. J Obstet Gynecol Neonatal Nurs. 2005 Nov-Dec;34(6):689-94. doi: 10.1177/0884217505281857.
Reference Type
BACKGROUND
Feldman R, Eidelman AI. Skin-to-skin contact (Kangaroo Care) accelerates autonomic and neurobehavioural maturation in preterm infants. Dev Med Child Neurol. 2003 Apr;45(4):274-81. doi: 10.1017/s0012162203000525.
Reference Type
BACKGROUND
Weissman A, Aranovitch M, Blazer S, Zimmer EZ. Heel-lancing in newborns: behavioral and spectral analysis assessment of pain control methods. Pediatrics. 2009 Nov;124(5):e921-6. doi: 10.1542/peds.2009-0598. Epub 2009 Oct 19.
Reference Type
BACKGROUND
Oberlander TF, Grunau RE, Fitzgerald C, Whitfield MF. Does parenchymal brain injury affect biobehavioral pain responses in very low birth weight infants at 32 weeks' postconceptional age? Pediatrics. 2002 Sep;110(3):570-6. doi: 10.1542/peds.110.3.570.
Reference Type
BACKGROUND
Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82. doi: 10.1097/ajp.0b013e3181ed1058.
Reference Type
BACKGROUND
Logier R, Jeanne M, Tavernier B, De Jonckheere J. Pain/analgesia evaluation using heart rate variability analysis. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:4303-6. doi: 10.1109/IEMBS.2006.260494.
Reference Type
BACKGROUND
Anand KJ, Aranda JV, Berde CB, Buckman S, Capparelli EV, Carlo W, Hummel P, Johnston CC, Lantos J, Tutag-Lehr V, Lynn AM, Maxwell LG, Oberlander TF, Raju TN, Soriano SG, Taddio A, Walco GA. Summary proceedings from the neonatal pain-control group. Pediatrics. 2006 Mar;117(3 Pt 2):S9-S22. doi: 10.1542/peds.2005-0620C.
Reference Type
BACKGROUND
Stapelkamp C, Carter B, Gordon J, Watts C. Assessment of acute pain in children: development of evidence-based guidelines. Int J Evid Based Healthc. 2011 Mar;9(1):39-50. doi: 10.1111/j.1744-1609.2010.00199.x.
Reference Type
BACKGROUND
Granot M, Ferber SG. The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45. doi: 10.1097/01.ajp.0000135236.12705.2d.
Reference Type
BACKGROUND
Kalkman JC, Visser K, Moen J, Bonsel JG, Grobbee ED, Moons MKG. Preoperative prediction of severe postoperative pain. Pain. 2003 Oct;105(3):415-423. doi: 10.1016/S0304-3959(03)00252-5.
Reference Type
BACKGROUND
Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.
Reference Type
BACKGROUND
Franck LS, Ridout D, Howard R, Peters J, Honour JW. A comparison of pain measures in newborn infants after cardiac surgery. Pain. 2011 Aug;152(8):1758-1765. doi: 10.1016/j.pain.2011.03.017. Epub 2011 Apr 21.
Reference Type
BACKGROUND
Smith MC, Stallings MA, Mariner S, Burrall M. Benefits of massage therapy for hospitalized patients: a descriptive and qualitative evaluation. Altern Ther Health Med. 1999 Jul;5(4):64-71.
Reference Type
BACKGROUND
Diego MA, Field T, Hernandez-Reif M, Deeds O, Ascencio A, Begert G. Preterm infant massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight gain. Acta Paediatr. 2007 Nov;96(11):1588-91. doi: 10.1111/j.1651-2227.2007.00476.x. Epub 2007 Sep 21.
Reference Type
BACKGROUND
Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
Reference Type
BACKGROUND
Voepel-Lewis T, Merkel S, Tait AR, Trzcinka A, Malviya S. The reliability and validity of the Face, Legs, Activity, Cry, Consolability observational tool as a measure of pain in children with cognitive impairment. Anesth Analg. 2002 Nov;95(5):1224-9, table of contents. doi: 10.1097/00000539-200211000-00020.
Reference Type
BACKGROUND
32. Wong DL, Hockenberry-Eaton M, Wilson D, et al. Wong's essentials of pediatric nursing (6th ed.). St. Louis: Mosby; 2001.
Reference Type
BACKGROUND
Jensen MP, Karoly P, O'Riordan EF, Bland F Jr, Burns RS. The subjective experience of acute pain. An assessment of the utility of 10 indices. Clin J Pain. 1989 Jun;5(2):153-9. doi: 10.1097/00002508-198906000-00005.
Reference Type
BACKGROUND
34. Spielberger CD. Conceptual and methodological issues in anxiety research. In C. D. Spielberger (Ed.), Anxiety: current trends in theory and research (pp. 481-492). New York: Academic Press; 1972.
Reference Type
BACKGROUND
Page MG, Fuss S, Martin AL, Escobar EM, Katz J. Development and preliminary validation of the Child Pain Anxiety Symptoms Scale in a community sample. J Pediatr Psychol. 2010 Nov;35(10):1071-82. doi: 10.1093/jpepsy/jsq034. Epub 2010 Apr 29.
Reference Type
BACKGROUND
Page GM, Campbell F, Isaac L, Stinson J, Martin-Pichora AL, Katz J. Reliability and validity of the Child Pain Anxiety Symptoms Scale (CPASS) in a clinical sample of children and adolescents with acute postsurgical pain. Pain. 2011 Sep;152(9):1958-1965. doi: 10.1016/j.pain.2011.02.053. Epub 2011 Apr 12.
Reference Type
BACKGROUND
Jenkins KJ, Gauvreau K, Newburger JW, Spray TL, Moller JH, Iezzoni LI. Consensus-based method for risk adjustment for surgery for congenital heart disease. J Thorac Cardiovasc Surg. 2002 Jan;123(1):110-8. doi: 10.1067/mtc.2002.119064.
Reference Type
BACKGROUND
Harrison TM, Brown R, Duffey T, Frey C, Bailey J, Nist MD, Renner L, Fitch J. Effects of Massage on Postoperative Pain in Infants With Complex Congenital Heart Disease. Nurs Res. 2020 Sep/Oct;69(5S Suppl 1):S36-S46. doi: 10.1097/NNR.0000000000000459.
Reference Type
DERIVED
Other Identifiers
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IRB11-00662
Identifier Type: -
Identifier Source: org_study_id
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