SurgeryNCT01738308
The Effects of Healing Touch on Post Operative Pediatric Patients
A study testing Healing Touch in people with Surgery and Stress, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on post-operative discomfort and the rate of recovery in children. The aims of this study are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/ emergence delirium (EAD), 3) pain, 4)… Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- What is being tested?
- Healing Touch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2017
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing
- 3 or 4 years old
- elective tonsillectomy with or without adenoidectomy
- o American Society of Anesthesiologist Classification (ASA) I without systemic disease
- o American Society of Anesthesiologist Classification (ASA) II: moderate systemic disease
- Parents speak and write English
Who cannot join
- Emergency surgery
- have a complicating diagnosis or chronic medical illness
- A history of chronic pain or use of analgesic drugs.
- Familiar or personal history of malignant hyperthermia
- Previous surgeries or hospitalizations
- Parents unable to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4
The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on post-operative discomfort and the rate of recovery in children. The aims of this study are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/ emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure criteria, 6.) maladaptive behaviors 2 weeks following surgery \& 7)readmissions for complications 2 weeks following surgery.
This is a triple blinded randomized controlled trial with three parallel groups. 240 subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the usual care plus a post-operative Healing Touch treatment, or the usual post-operative care plus a sham Healing Touch treatment done by an untrained research assistant. The participants \& parents, the evaluators, and the principle investigator will be blinded to study group assignment.
Read the detailed description
ABSTRACT:
Tonsillectomies and adenoidectomies (T\&A) are the most commonly performed pediatric surgeries (NIH, 2010). Surgery is understandably anxiety provoking for children and for their families. Research has shown that anxiety influences post-operative recovery (Kain, 2004, 2012; Lynch, 1998; Schisler, 1998; Vaurio, 2006). Anxiety, emergence agitation and emergence delirium (EA/D) and pain during recovery from general anesthesia have been identified as frequent problems in the pediatric population, particularly with younger children (Key, 2010) and these have been related to increases in length of stay. Perioperative stress often has prolonged effects. After surgery, 88% of all children develop new-onset post-operative maladaptive behavioral changes. These changes refer to developmental regression and behaviors that interfere with daily functioning such as general anxiety, nighttime crying, enuresis, separation anxiety, night terrors, temper tantrums etc). Alarmingly, 54% of all children demonstrate maladaptive behaviors 2 weeks following surgery and 20% of these children continue to demonstrate negative behaviors 6 months postoperatively. Research has shown that younger children are at even higher risks (Kain, 2004; Watson, 2003).
Healing Touch is a biofield therapy that has been shown to decrease pain and anxiety in adults (Im, 2009; Jain, 2010) and in premature infants (Hanley, 2008; Im, 2009, Whitley, 2008). For several years Holistic Health Specialist Nurses trained in Healing Touch have been doing Healing Touch in Cincinnati Children's Hospital Medical Center's Post Anesthesia Care Unit (CCHMC's PACU). Nurses anecdotally have noted that patients who receive Healing Touch seem to wake up calmer, often need less pain medication and are less stressful after their surgeries. CCHMC nurses have reported that Healing Touch is especially useful with anxious children and younger children. Healing Touch (HT) is a complementary therapy that is a non-invasive, low-cost therapy without known side effects that can easily be incorporated into post-operative care routines.
The desired study outcomes in the Healing Touch treatment group are:
- Lower anxiety levels, measured by differences in the Perioperative Adult Child Behavioral Interaction Scale(PACBIS) scores pre \& postoperatively. This is a behavioral assessment of the child's coping and distress and the parents positive and negative behavior. Parent will also self evaluated their distress and anxiety. The Healing Touch group will have a lower sympathetic response as measured by preoperative and sequential post-operative B/P, Pulse, Respirations, \& pulse oximetry
- Less emergence agitation and delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED)scores, an observational scale which will be done sequentially once they enter the recovery room
- Less pain as measured by the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale and significantly less pain medication usage
- Waking up more slowly once they enter the PACU
- Shorter length of stay in the PACU, measured by meeting PACU's discharge criteria.
- Significantly less regression and maladaptive behaviors measured by the Post-Hospital Behavior Questionnaire (PHBQ) 2 weeks following surgery.
- Fewer readmissions for complications 2 weeks following surgery as identified by family guardian in the 2 week follow up call.
The significance of this study is that its outcomes will add to the body of knowledge about the practice of Healing Touch with children, and may provide evidence substantiating the benefits of Healing Touch on post-operative pediatric patients. This may lead to the incorporation of Healing Touch into pediatric nursing practice. Preschool children are at higher risk for extended stressful responses to surgery, i.e. regression and maladaptive behaviors (Vernon, 1966). Preschoolers have vivid imaginations and magical thinking. They may have trouble telling fantasy from reality. The often develop fears related to new places and experiences and separation from parents. There have been no identified effective supportive measures to improve this protracted stress outcome. Healing Touch may be a tool that can comfort and support this vulnerable population and may be helpful with other hospitalized children.
- Conditions
- Surgery, Stress, Pain, Children, Post-Traumatic Stress Disorder
- Being tested
- Healing Touch, Healing Touch Sham Treatment
- Keywords
- Healing Touch, Pediatrics, surgery, stress, pain, Pediatric Stress, maladaptive behaviors, energy medicine, emergence delirium, emergence agitation, length of stay, ease of wake up, distress parents, distress pediatric patients, Pediatric Post-Traumatic Stress Disorder
- Medical subject headings
- Pain, Stress Disorders, Post-Traumatic, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing TouchProcedure or surgery
Also called Energy Therapy, Reiki
When enter PACU + usual standard of care.
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,
Healing Touch Sham TreatmentProcedure or surgery
Also called Presence
The untrained in energy work study staff will be at the bedside when the patient is first brought to the PACU. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. This will continue until parents are called to the bedside
| Study group | Role | What they receive |
|---|---|---|
| Healing Touch Treatment | Experimental | Healing Touch Treatment
When enter PACU + usual standard of care.
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, Receives: Procedure: Healing Touch |
| Sham Healing Touch Treatment | Sham comparator | Usual standard of post operative care plus a sham Heal Touch treatment upon entering the post anesthesia care unit. Treatment done by untrained study staff using same hand locations. Receives: Procedure: Healing Touch Sham Treatment |
| Control- No treatment done | No intervention | Usual standard of post operative care with no additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Anxiety
- Perioperative Adult Child Behavioral Interaction Scale (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 Weeks after surgery will do PHBQ (Post Hospital Behavioral Questionaire)to assess childs adaptation
Measured: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery
Secondary outcomes (1)
2. Emergence agitation/ emergence delirium
PAED scale done every 5 minutes for the first 30 minutes post op Evaluated from videotape by blinded evaluator
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startSep 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Holistic Nurses Association (AHNA)
- Responsible party
- Sponsor
- Investigators
- Wendy Grace K Rolf, MSN CHTP AHN, Principal investigator, Cincinnati Childrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738308
- Sponsor's protocol ID
- 2011-1572
- Status last verified
- Jun 2021
- First submitted
- 28 Nov 2012
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4
- ClinicalTrials.gov ID
- NCT01738308
- Acronym / sponsor ID
- 2011-1572
- Conditions
- Surgery, Stress, Pain, Children, Post-Traumatic Stress Disorder
- Keywords
- Healing Touch, Pediatrics, surgery, stress, pain, Pediatric Stress, maladaptive behaviors, energy medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- American Holistic Nurses Association (AHNA)
- Study start
- Sep 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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 goal of this study is to assess the benefits of Healing Touch, an energy based therapy on post-operative discomfort and the rate of recovery in children. The aims of this study are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/ emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure criteria, 6.) maladaptive behaviors 2 weeks following surgery \& 7)readmissions for complications 2 weeks following surgery.
This is a triple blinded randomized controlled trial with three parallel groups. 240 subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the usual care plus a post-operative Healing Touch treatment, or the usual post-operative care plus a sham Healing Touch treatment done by an untrained research assistant. The participants \& parents, the evaluators, and the principle investigator will be blinded to study group assignment.
Detailed description
ABSTRACT:
Tonsillectomies and adenoidectomies (T\&A) are the most commonly performed pediatric surgeries (NIH, 2010). Surgery is understandably anxiety provoking for children and for their families. Research has shown that anxiety influences post-operative recovery (Kain, 2004, 2012; Lynch, 1998; Schisler, 1998; Vaurio, 2006). Anxiety, emergence agitation and emergence delirium (EA/D) and pain during recovery from general anesthesia have been identified as frequent problems in the pediatric population, particularly with younger children (Key, 2010) and these have been related to increases in length of stay. Perioperative stress often has prolonged effects. After surgery, 88% of all children develop new-onset post-operative maladaptive behavioral changes. These changes refer to developmental regression and behaviors that interfere with daily functioning such as general anxiety, nighttime crying, enuresis, separation anxiety, night terrors, temper tantrums etc). Alarmingly, 54% of all children demonstrate maladaptive behaviors 2 weeks following surgery and 20% of these children continue to demonstrate negative behaviors 6 months postoperatively. Research has shown that younger children are at even higher risks (Kain, 2004; Watson, 2003).
Healing Touch is a biofield therapy that has been shown to decrease pain and anxiety in adults (Im, 2009; Jain, 2010) and in premature infants (Hanley, 2008; Im, 2009, Whitley, 2008). For several years Holistic Health Specialist Nurses trained in Healing Touch have been doing Healing Touch in Cincinnati Children's Hospital Medical Center's Post Anesthesia Care Unit (CCHMC's PACU). Nurses anecdotally have noted that patients who receive Healing Touch seem to wake up calmer, often need less pain medication and are less stressful after their surgeries. CCHMC nurses have reported that Healing Touch is especially useful with anxious children and younger children. Healing Touch (HT) is a complementary therapy that is a non-invasive, low-cost therapy without known side effects that can easily be incorporated into post-operative care routines.
The desired study outcomes in the Healing Touch treatment group are:
- Lower anxiety levels, measured by differences in the Perioperative Adult Child Behavioral Interaction Scale(PACBIS) scores pre \& postoperatively. This is a behavioral assessment of the child's coping and distress and the parents positive and negative behavior. Parent will also self evaluated their distress and anxiety. The Healing Touch group will have a lower sympathetic response as measured by preoperative and sequential post-operative B/P, Pulse, Respirations, \& pulse oximetry
- Less emergence agitation and delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED)scores, an observational scale which will be done sequentially once they enter the recovery room
- Less pain as measured by the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale and significantly less pain medication usage
- Waking up more slowly once they enter the PACU
- Shorter length of stay in the PACU, measured by meeting PACU's discharge criteria.
- Significantly less regression and maladaptive behaviors measured by the Post-Hospital Behavior Questionnaire (PHBQ) 2 weeks following surgery.
- Fewer readmissions for complications 2 weeks following surgery as identified by family guardian in the 2 week follow up call.
The significance of this study is that its outcomes will add to the body of knowledge about the practice of Healing Touch with children, and may provide evidence substantiating the benefits of Healing Touch on post-operative pediatric patients. This may lead to the incorporation of Healing Touch into pediatric nursing practice. Preschool children are at higher risk for extended stressful responses to surgery, i.e. regression and maladaptive behaviors (Vernon, 1966). Preschoolers have vivid imaginations and magical thinking. They may have trouble telling fantasy from reality. The often develop fears related to new places and experiences and separation from parents. There have been no identified effective supportive measures to improve this protracted stress outcome. Healing Touch may be a tool that can comfort and support this vulnerable population and may be helpful with other hospitalized children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healing Touch Treatment | Experimental | Procedure: Healing TouchHealing Touch Treatment When enter PACU + usual standard of care. 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, |
| Sham Healing Touch Treatment | Sham comparator | Procedure: Healing Touch Sham TreatmentUsual standard of post operative care plus a sham Heal Touch treatment upon entering the post anesthesia care unit. Treatment done by untrained study staff using same hand locations. |
| Control- No treatment done | No intervention | –Usual standard of post operative care with no additional intervention |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Typically developing
- 3 or 4 years old
- elective tonsillectomy with or without adenoidectomy
- o American Society of Anesthesiologist Classification (ASA) I without systemic disease
- o American Society of Anesthesiologist Classification (ASA) II: moderate systemic disease
Key exclusion criteria (6 listed)
- Emergency surgery
- have a complicating diagnosis or chronic medical illness
- A history of chronic pain or use of analgesic drugs.
- Familiar or personal history of malignant hyperthermia
- Previous surgeries or hospitalizations
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 |
|---|---|---|
| Healing TouchAlso: Energy Therapy, ReikiWhen enter PACU + usual standard of care. 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, | Procedure or surgery | Healing Touch Treatment |
| Healing Touch Sham TreatmentAlso: PresenceThe untrained in energy work study staff will be at the bedside when the patient is first brought to the PACU. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. This will continue until parents are called to the bedside | Procedure or surgery | Sham Healing Touch Treatment |
Primary outcome
1. Anxiety
Time frame: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery
1. Perioperative Adult Child Behavioral Interaction Scale (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 2. Biologic measures: vital signs (B/P, pulse, and pulse oximetry) pre-operatively and sequentially post operatively done by PACU nurses. 3. 2 Weeks after surgery will do PHBQ (Post Hospital Behavioral Questionaire)to assess childs adaptation
1 secondary outcome
2. Emergence agitation/ emergence delirium
Time frame: Day of Surgery
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 24 Jun 2021.
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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.
Wendy Grace K Rolf, MSN CHTP AHN principal investigator
Cincinnati Childrens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Touch in people with Surgery and Stress, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 6 inclusion and 6 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 24 Jun 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 United States. 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. Some participants in this study may receive a placebo. 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?
1. Anxiety (time frame: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2021.