A randomised controlled trial of the effects of the energy-based complementary therapy of healing touch on the functional health status of community-dwelling single older women
Wicking, Kristin Edith Grantham (2012) A randomised controlled trial of the effects of the energy-based complementary therapy of healing touch on the functional health status of community-dwelling single older women. PhD thesis, James Cook University.
|
PDF (Thesis)
Download (4MB) | Preview |
Abstract
BACKGROUND: Both government and the health care industry are keenly aware of the burgeoning older adult population in Australia and globally. The risk for functional decline leading to placement in residential aged care is accentuated for older women who live alone, who may experience lower social support and/or touch deprivation. Frail older adults in one prior small qualitative study reported gains in functional ability after receiving Healing Touch treatments, while findings from two prior experimental studies with methodological limitations contributed suggestive but conflicting evidence for the benefit of Healing Touch on functional ability for hospice patients and women with cancer. The aim of this research was to clarify the existing evidence base with a methodologically rigorous placebo-controlled trial of adequate power to detect an effect on functional health. A series of weekly sessions of the complementary therapy of Healing Touch was provided in the homes of community-dwelling women to ascertain if this nursing intervention, which uses gentle direct and indirect touch on specific locations of the body in a prescribed sequence for each technique, could assist them in managing and optimising their current functional and global health status, as well as providing them with a source of healthy touch and social connection.
TRIAL DESIGN: A parallel, two-arm randomised placebo-controlled trial was conducted to assess the effects of the energy-based complementary therapy of Healing Touch on the functional, social, psychological and spiritual health status and overall quality of life of community dwelling older women.
METHODS: Participants/Setting: Inclusion criteria: women over 65 living alone in the community in a regional city in northern Australia in houses, units or retirement villas, who were receiving some assistance in their homes from any source including family, friends, neighbours or volunteers. Exclusion criteria were existing cognitive impairment, the presence of a room-mate or live-in caregiver, or recent experiences with Healing Touch or other similar energy-based touch therapies. Participants received a series of weekly treatments of Healing Touch or mimic healing touch (placebo) in their residences between January 2009 and December 2010. A Research Assistant blinded to group allocation collected the data in the participants' residences at baseline (Week 0), at completion of the seven week treatment series (Week 8), and six months after completion of the treatment series (Week 33).
Interventions: Participants in the Healing Touch group received a series of seven weekly treatments, each lasting an average of 30 minutes, consisting of one of 35 possible Healing Touch techniques, from the established curriculum taught by the Colorado Center for Healing Touch and approved by the American Holistic Nurses Association. Timing and duration of sessions were similar for the participants in the placebo group, who received one mimic healing touch technique as per the placebo protocol developed by the Principal Investigator(PI). The PI delivered all interventions to preserve blinding and ensure protocol adherence.
Hypothesis: The Healing Touch group will experience statistically significantly smaller declines in functional health than the placebo group.
Outcome Measures: The primary outcome was functional health as measured by the Older American Resources Survey’s Functional Multidimensional Assessment Questionnaire (OARS-FMAQ), consisting of two sub-scales: Basic Activities of Daily Living (ADLs) and Instrumental ADLs, which are summed for a Total ADL score. Secondary outcome measures included the Medical Outcomes Study Social Support Survey (MOS-SSS), the Paloutzian and Ellis Spiritual Well-Being Scale, the Ryff Psychological Well-Being Scale-short form, and the Duke Health Profile.
Randomisation: Computer generated random numbers were used to create a sequence of blocked and balanced random allocations, in groups of ten, concealed in opaque envelopes. Participants were advised of the placebo design prior to consent. Envelopes were opened by the PI immediately prior to administering the selected protocol at the first treatment session.
Blinding: Participants, family members, referral sources, co-providers, data collectors and data analysis verifiers were blinded to group allocation.
RESULTS: Number of participants: 191 women were screened and enrolled, but 18 did not keep their appointments and 5 failed their screening MMSE, leaving 168 who progressed to randomisation: 84 participants in each treatment group. Attrition causes included: onset of illness (5); death (1); relocation (4); too busy for appointments (1) or participants being unable to tolerate lying on the massage table and/or wearing the sleeping mask (4). A modified intention-to-treat analysis was conducted for the 153 participants with data from all three time points, regardless of protocol adherence: 75 participants in the placebo group and 78 in the Healing Touch group.
Outcome Measures: Despite randomisation, treatment groups were not comparable on the key demographic variable of living arrangement, with a greater number of retirement village residents in the Healing Touch group, thus requiring a stratified analysis.
For the stratum of participants already living in retirement villages, there was a statistically significant difference (p = 0.025) between the change in the Healing Touch group's scores from Week 0 to Week 33 as compared to the change in the placebo group's scores, on the Basic Activities of Daily Living (BADL) sub-scale. The Healing Touch group showed a small but clinically relevant improvement in the BADL sub-scale (median 0.0, inter-quartile range 0.0, +1.0), while the placebo group showed a small but clinically relevant decline (median 0.0, inter-quartile range -1.0, 0.0).
The change over time in the two other measures of functional health, the Instrumental Activities of Daily Living (IADL) sub-scale and the Total ADL scale, were comparable between the Healing Touch group and the placebo group for the retirement village stratum; and all functional health measures (BADL, IADL, and Total ADL) were comparable between the two treatment groups for the stratum of participants living in their own homes or units in ordinary residential neighbourhoods.
The Social Support measure also showed a statistically significant difference (p = 0.012) between treatment groups, but only in the stratum of participants still living in their own homes or units in ordinary residential neighbourhoods. Again the Healing Touch group showed a modest improvement from Week 0 to Week 33, while the placebo group showed a decline.
Harms: No harms related to the treatment were reported, although alternative positions in a reclining chair or shorter treatments were required for 4 participants who could not tolerate lying supine on the massage table for a full treatment session.
CONCLUSION: Healing Touch may have a beneficial effect for selected older adult populations on selected health dimensions, depending on their area of deficit:
1. Retirement village residents may respond with improvements in their functional health. These findings are congruent with some of the earlier qualitative and experimental research on functional health, but conflict with more recent RCTs with younger but acutely ill participants.
2. Socially isolated residents in ordinary residential neighbourhoods may respond with improvements in their social health. These findings conflict with earlier studies of younger but acutely ill participants, where no benefits for social health were observed.
TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry Number ACTRN12612000788875. World Health Organisation Universal Trial Number is 1111-1132-2783.
Actions (Repository Staff Only)
 |
Item Control Page |