Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000788875
Ethics application status
Approved
Date submitted
15/07/2012
Date registered
25/07/2012
Date last updated
26/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Clinical Trial (RCT) of the effects of the energy-based complementary therapy of Healing Touch versus placebo on the functional health of community dwelling older women.
Scientific title
The effect on community dwelling older women

of Healing Touch versus Placebo

for the prevention of functional decline
Secondary ID [1] 280907 0
None
Universal Trial Number (UTN)
1111-1132-2783
Trial acronym
Healing Touch Supports Healthy Older Women
HT-SHOW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional decline 286916 0
Social support 286917 0
Functional health 286964 0
Condition category
Condition code
Alternative and Complementary Medicine 287244 287244 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Series of seven weekly sessions of Healing Touch treatments delivered in the participant's home. All sessions delivered by the same Level 4 trained Healing Touch registered nurse.
Treatment time generally averaged 30 min, with rare exceptions of 20 minutes for 2 participants who could not tolerate supine position on massage table, and with 0-1 of 7 treatments in each participant's series extending beyond 30 min to a maximum of 40 minutes, depending on the technique being used for that treatment session.


Healing Touch is an energy-based therapy that uses gentle touch on or above the body in particular locations in a specific sequence that differs for each of the 35 techniques within the established curriculum certified by the American Holistic Nurses Association. A different technique was used each week.

Participants in both the intervention group and the comparator group were settled on to a massage table provided by the Healing Touch Nurse, and positioned with pillows for comfort and proper anatomical alignment, fully clothed except shoes. A lightweight sheet was placed over the participant for comfort and to prevent tactile perception of the provider's skin versus the placebo touch, after which a soft sleeping mask and ear plugs (to reduce sensory interruption and to maintain masking to group allocation) were applied by the Healing Touch Nurse. Techniques were chosen based on taking a short history at each home visit, and on an energetic assessment. Vital signs were taken before and after each treatment session for both groups.
Intervention code [1] 285275 0
Treatment: Other
Intervention code [2] 285276 0
Prevention
Comparator / control treatment
Series of seven weekly sessions of mimic healing touch (placebo) treatments delivered in the participant's home, delivered by the same provider as active treatment, to preserve participant blinding. Treatment time generally averaged 30 min, with the rare exception of 15 -20 minutes for 1 participant who could not tolerate lying still with the sleeping mask applied for longer than 15 -20 minutes related to anxiety issues.

Participants in both the intervention group and the comparator group were settled on to a massage table provided by the Healing Touch Nurse, and positioned with pillows for comfort and proper anatomical alignment, fully clothed except shoes. A lightweight sheet was placed over the participant for comfort and to prevent tactile perception of the provider's skin versus the placebo touch, after which a soft sleeping mask and ear plugs (to reduce sensory interruption and to maintain masking to group allocation) were applied by the Healing Touch Nurse.

Mimic techniques were done after taking a short history at each home visit. Vital signs were taken before and after each treatment session for both groups.

A repertoire of 10 placebo techniques were created and administered by the same Healing Touch Nurse, to preserve participant blinding to group allocation. A different technique was used each week, as occurred for the Intervention group. Techniques were given the same names as actual Healing Touch techniques to preserve participant blinding in case they observed the Healing Touch Nurse making chart notations or spoke to other participants in the study. Typically mimic direct touch techniques at one treatment session were alternated with indirect touch mimic techniques at the next treatment session, to preserve participant blinding to group allocation.

Placebo techniques simulated both direct touch and indirect touch. Direct touch was simulated by the placement of soft leather gloves filled with an inert material to mimic the weight and texture of the provider's hands, and kept in place for 5 minutes in locations on the body not used for actual Healing Touch techniques, in a pre-determined sequence for each placebo technique, always placed with the top sheet between the participant's clothed body and the gloves.

Indirect touch was simulated by the use of an A5 size laminated booklet (Healing Touch Technique Review Cards produced by the Colorado Center for Healing Touch), which were used in a gently sweeping motion around the participant's body, in a pre-determined sequence for each created placebo technique, with one sweep approximately every minute.

In addition, the Healing Touch Nurse refrained from the usual practice of grounding, centering and attuning to the participant prior to administering the placebo techniques, and purposefully engaged in unrelated cognitive functions to avoid any inadvertent focus on the participant at hand.
Control group
Placebo

Outcomes
Primary outcome [1] 287525 0
Functional health as measured by the Basic Activities of Daily Living and Instrumental Activities of Daily Living sub-scales of the Older American Resources Survey Multidimensional Functional Assessment Questionnaire.
Timepoint [1] 287525 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [1] 298318 0
Social support as measured by the Medical Outcomes Study Social Support Survey
Timepoint [1] 298318 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [2] 298319 0
Psychological well being as measured by the Ryff Psychological Well Being scale, short form (18 items)
Timepoint [2] 298319 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [3] 298320 0
Spiritual well being, as measured by the Paloutzian & Ellis Spiritual Well Being scale.
Timepoint [3] 298320 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [4] 298321 0
Quality of Life, as measured by the Duke Health Profile
Timepoint [4] 298321 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [5] 298322 0
Cognitive Health, as measured by the Mini Mental Status Exam
Timepoint [5] 298322 0
Within 2 weeks prior to commencement of series of treatment.
Within one week of completion of series of treatments.
Six months after completion of series of treatments
Secondary outcome [6] 298323 0
Vital Signs: temperature, pulse, respirations, systolic and diastolic blood pressure.
Temperature was assessed using a digital oral thermometer. Blood pressures were obtained by use of a stethoscope and an analog syphgnomanometer on the left arm only. Pulse and respiratory rates were obtained by placement of the stethoscope on the participant's upper chest, counting for 30 seconds for pulse and then another 30 seconds for respirations, and then doubling the rates to obtain a rate per minute for charting. Participants were told their heartbeat was being counted, but were not told their breaths per minute were being counted, to avoid conscious alteration of respiratory rate.
Timepoint [6] 298323 0
Before and after each of 7 treatments in the series
Secondary outcome [7] 298324 0
Participant self-ratings on a 0-10 scale of health status on four dimensions: physical health, emotional health, intellectual health and spiritual health.
Timepoint [7] 298324 0
Before and after each of 7 treatments in the series

Eligibility
Key inclusion criteria
Living alone in the community in a house, unit or retirement village; receiving some assistance from family, friends, neighbours, volunteers or paid assistants for either home, yard, meals, transport, hygiene or nursing services; able to speak, read and write English.
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No cognitive impairment (score of 28 or above on Mini Mental Status Exam);
No prior Healing Touch treatments;
No recent or frequent Therapeutic Touch or Reiki treatments.
No roommate or live-in caregiver

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Interested participants were screened by phone for eligibility criteria, verbally consented, enrolled, assigned a unique participant identification code, and scheduled for data collection and treatment appointments. After passing their screening MMSE at the baseline data collection point, prior to the next day's appointments, the treatment provider took the next available allocation envelope and inserted it in to each participant's chart, in order of appointment times.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers were used to create balanced blocks of ten allocations, kept in opaque envelopes, allocated to participants in order of their first treatment appointment time, and opened by treatment provider immediately prior to administering first treatment session.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants were provided with a soft cloth sleeping mask and ear plugs, similar to those provided on international flights, to preserve participant blinding to treatment allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5535 0
4819
Recruitment postcode(s) [2] 5536 0
4810
Recruitment postcode(s) [3] 5537 0
4811
Recruitment postcode(s) [4] 5538 0
4812
Recruitment postcode(s) [5] 5539 0
4814
Recruitment postcode(s) [6] 5540 0
4817
Recruitment postcode(s) [7] 5541 0
4815
Recruitment postcode(s) [8] 5542 0
4818
Recruitment postcode(s) [9] 5543 0
4820

Funding & Sponsors
Funding source category [1] 285634 0
University
Name [1] 285634 0
James Cook University
Country [1] 285634 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
Angus Smith Drive
Townsville, Queensland, 4811
Country
Australia
Secondary sponsor category [1] 284523 0
None
Name [1] 284523 0
Address [1] 284523 0
Country [1] 284523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287632 0
Townsville Health Service District Human Research Ethics Committee
Ethics committee address [1] 287632 0
Ethics committee country [1] 287632 0
Australia
Date submitted for ethics approval [1] 287632 0
19/06/2008
Approval date [1] 287632 0
16/07/2008
Ethics approval number [1] 287632 0
35/08
Ethics committee name [2] 287633 0
James Cook University
Ethics committee address [2] 287633 0
Ethics committee country [2] 287633 0
Australia
Date submitted for ethics approval [2] 287633 0
18/07/2008
Approval date [2] 287633 0
22/08/2008
Ethics approval number [2] 287633 0
H3077

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34385 0
Address 34385 0
Country 34385 0
Phone 34385 0
Fax 34385 0
Email 34385 0
Contact person for public queries
Name 17632 0
Kristin Wicking
Address 17632 0
School of Nursing Midwifery & Nutrition
James Cook University
Angus Smith Drive
Townsville, Queensland, 4811
Country 17632 0
Australia
Phone 17632 0
61-7-4781-5353
Fax 17632 0
61-7-4781-4026
Email 17632 0
[email protected]
Contact person for scientific queries
Name 8560 0
Kristin Wicking
Address 8560 0
School of Nursing Midwifery & Nutrition
James Cook University
Angus Smith Drive
Townsville, Queensland, 4811
Country 8560 0
Australia
Phone 8560 0
61-7-4781-5353
Fax 8560 0
61-7-4781-4026
Email 8560 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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