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NCT04416230
Post-Op Massage in Infants With Congenital Heart Disease
NA trial testing massage in Congenital Heart Disease in 65 participants. Completed in 30 May 2014.
3 August 2013
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 May 2012 |
| Primary completion | 3 August 2013 |
| Estimated completion | 30 May 2014 |
Drugs / interventions tested
- massage — full drug profile →
- quiet time
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
Sponsor
Ohio State University
Who can join
Adults 1 Day to 12 Months, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04416230
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of massage
Trials testing the same drug.
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- NCT06539858 — Investigation of the Effect of Massage Application on Functional Status and Depression in Postpartum Mothers · completed
- NCT07305545 — Investigation of the Effect of Massage Therapy on Sleep Duration and Mother-Baby Bonding in Newborn · completed
- NCT05974761 — Clinical Observation on the Treatment of Massage Based on Fascia Chain · NA · unknown
Other recruiting trials for Congenital Heart Disease
Currently open trials in the same condition.
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- NCT06833320 — Propranolol Treatment for Postoperative Chylothorax · Phase 1, PHASE2 · recruiting
- NCT06668389 — Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary · Phase 4 · recruiting
- NCT06872320 — The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease · NA · active not recruiting
Other Ohio State University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04416230 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University
- Last refreshed: 4 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04416230.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing