TriangleNCT02589938 · OUTCOME
The Acupuncture Expectancy Scale (AES)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale 4-20
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 4
What was measured
The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20.
Analysis population: Intent to treat analysis excluding standard oral hygiene group. Considered and utilized all data available at each timepoint. AES was not collected for the standard oral hygiene arm per protocol specifications. Standard oral hygiene participants were not to receive any form of acupuncture making this outcome not applicable for these participants and therefore not collected.
Groups in this outcome
Standard Oral Hygiene + True Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
Standard Oral Hygiene + Sham Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
| Group | Source count |
|---|---|
| Standard Oral Hygiene + True Acupuncture | 86 |
| Standard Oral Hygiene + Sham Acupuncture | 86 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene + True Acupuncture | 10.8 | Not reported | 10.0 | 11.5 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 10.7 | Not reported | 9.9 | 11.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.0
- upper Limit
- 11.5
- value
- 10.8
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 11.5
- value
- 10.7
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 86
- units
- Participants
- description
- The 4-item AES was used to ensure there were no baseline group differences in expectations related to the benefits of acupuncture on dry mouth and to assess aspects of blinding after the first 4 weeks of acupuncture for the TA and SA groups. The AES is reliable (α=0·82) and valid by positive correlation with patient self-reported efficacy and satisfaction. The scale has been further validated among cancer patients who were acupuncture naïve. Scale from 4-20.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG000
- title
- Standard Oral Hygiene + True Acupuncture
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG001
- title
- Standard Oral Hygiene + Sham Acupuncture
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Intent to treat analysis excluding standard oral hygiene group. Considered and utilized all data available at each timepoint. AES was not collected for the standard oral hygiene arm per protocol specifications. Standard oral hygiene participants were not to receive any form of acupuncture making this outcome not applicable for these participants and therefore not collected.
- reporting Status
- POSTED
- time Frame
- Week 4
- title
- The Acupuncture Expectancy Scale (AES)
- type
- SECONDARY
- unit Of Measure
- score on a scale 4-20
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice