The Effects of Healing Touch on Post Op T&A Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess whether HT indeed has post-operative benefits in children. The hypothesis of this study is that children who receive a post-operative HT treatment will have less postsurgical discomfort than those who do not receive a HT treatment. To test the hypothesis, the research questions are will children receiving a HT treatment following tonsillectomy / adenoidectomy: 1) have less anxiety / distress, 2) have less agitation/delirium, 3) have less pain, 4) recover faster, 5) be discharged sooner, and 6) have fewer maladaptive behaviors than those not receiving a HT treatment? To provide answers to the research questions, the specific aims of the study are to evaluate the effect of HT on post-operative: 1) anxiety / distress / coping behavior, 2) emergence agitation/delirium, 3) pain, 4) time to wake up, 5) time to meet PACU's departure criteria, and 6) behavior changes 2 weeks following surgery. The study design is a double-blind randomized controlled clinical trial with three parallel groups: 240 participants, 3 or 4 years of age, will be randomly assigned to receive the usual post-operative care (control group) or the usual care plus a post-operative HT treatment (treatment group) or the usual care plus a sham HT treatment (attention group).
| Condition | Intervention |
|---|---|
|
Surgery Stress Pain Children Healing Touch |
Procedure: Healing Touch Treatment Group Procedure: Sham Healing Touch Treatment Procedure: Control Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4 |
- 1. Anxiety [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
- PABCIS behavioral and self-assessments pre operatively and post-operatively by blinded research assistants. This scale is a behavioral assessment of the child/ adult behavioral interactions in the perioperative period. Parents will be asked to provide self-assessments of their distress in the preoperative and post-operative period. Parents will use Likert scales
- Biologic measures: vital signs (B/P, pulse, and pulse oximetry) pre-operatively and sequentially post operatively done by PACU nurses.
- 2. Emergence agitation/ emergence delirium [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]PAED scale done every 5 minutes for the first 30 minutes post op Evaluated from videotape by blinded evaluator
- 3. Pain: [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
- FLACC pain scores evaluated by bedside nurses when first enter PACU & every 15 min for first hour, every 30 minutes 2nd hour, then every hour until discharge
- Assessor, blinded observer will evaluate pain on videotape using modified FLACC scale when subject first arrives in PACU at 15min and 30 minutes and at time when subject meets departure criteria
- These FLACC scores done by staff nurses and by assessor will be compared.
- Frequency and dose of pain medications (Pre-op/ during surgery/ & post-op)
- Type and duration of anesthetic agents will be analyzed.
- 4. Time to wake up [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
- From time patient enters the PACU until awake and alert.
- Videotape evaluation by blinded observer
- 5. Length of stay in the PACU: [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]a. Difference in recorded times-- when subject enters PACU and time subject meets PACU departure criteria as evaluated by PACU nurse. Departure criteria include: Patient is 1. Alert & oriented to place and person and appropriate for age and mental status. 2. Vital signs are stable compared to pre-operative 3. No excessive vomiting as compared to pre-operative 4. Pain is satisfactorily controlled
- 6. Maladaptive behaviors [ Time Frame: 2 Weeks Post operativly ] [ Designated as safety issue: No ]
- PHBQ done 2 weeks post operatively (When postoperative pain should no longer be a factor).
- This will be done by a phone call to subject's house
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3 year old
Healing Touch Treatment Sham Healing Touch Treatment Usual care only
|
Procedure: Healing Touch Treatment Group
The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. The practitioner will hold this position until they feel a deep connection and "quieting" within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,
Other Names:
Procedure: Sham Healing Touch Treatment
The sham practitioner will be instructed to hold their hands in the same position as the Healing Touch practitioner. They will remove their hands when the child awakens and will leave before the parent arrives at the bedside.
Other Names:
Procedure: Control Group
Usual standard of care post operatively
Other Names:
|
|
Experimental: 4 year old
Healing Touch Treatment Sham Healing Touch Treatment Usual care only
|
Procedure: Healing Touch Treatment Group
The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. The practitioner will hold this position until they feel a deep connection and "quieting" within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,
Other Names:
Procedure: Sham Healing Touch Treatment
The sham practitioner will be instructed to hold their hands in the same position as the Healing Touch practitioner. They will remove their hands when the child awakens and will leave before the parent arrives at the bedside.
Other Names:
Procedure: Control Group
Usual standard of care post operatively
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years to 4 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Typically developing male and female children, 3 or 4 years of age, having an elective tonsillectomy with or without adenoidectomy. Participants are classified American Society of Anesthesiologist (ASA) I without systemic disease, or ASA II moderate systemic disease. Parents will have the ability to speak and write English for the purposes of obtaining informed consent and evaluating the child's anxiety, distress, and coping behavior 2 weeks following surgery
Exclusion Criteria:
Emergency surgery Patients who have a complicating diagnosis such as chronic medical illness will be excluded.
A history of chronic pain or use of analgesic drugs. Familiar or personal history of malignant hyperthermia Children with previous surgeries or hospitalizations will be excluded Parents unable to understand English for the purposes of obtaining informed consent and evaluating child's anxiety level
-
Contacts and Locations| Contact: Wendy Grace K Rolf, MSN | 513-736-2245 ext pager | wendy.rolf@cchmc.org |
| Contact: Lois H Bogenschutz, BSN | 513-803-0788 | lois.bogenschutz@cchmc.org |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Not yet recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Wendy Grace K Rolf, MSN 513-736-2245 ext pager wendy.rolf@cchmc.org | |
| Principal Investigator: Wendy Grace K Rolf, MSN | |
| Sub-Investigator: Devin Devin, MS, RN | |
| Sub-Investigator: Lois Bogenschutz, BS, RN, CCRP | |
| Sub-Investigator: Li Lin, MS | |
| Sub-Investigator: Monica Meier, BSN, CHTP | |
| Sub-Investigator: Diane Wardell, PhD | |
| Sub-Investigator: Michelle Zimmer, MD | |
| Principal Investigator: | Wendy Grace K Rolf, MSN CHTP AHN | Cincinnati Childrens |
More Information
No publications provided
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01738308 History of Changes |
| Other Study ID Numbers: | 2011-1572 |
| Study First Received: | November 28, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
Pediatrics surgery Healing Touch stress pain maladaptive behaviors energy medicine |
emergence delirium emergence agitation length of stay ease of wake up distress parents distress pediatric patients |
ClinicalTrials.gov processed this record on May 23, 2013