Clinical trial NCT02525445: Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation
Official title: Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: placebo effects
communication
acupuncture therapy
relaxation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.

Detailed description: Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.

Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.

Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.

Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Able to understand and read/write Swedish

Exclusion Criteria:

* No acupuncture training

Primary outcomes:
measure: Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)
timeFrame: approximately 5 minutes before treatment and approximately 5 minutes after treatment
Secondary outcomes:
measure: Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)
timeFrame: approximately 5 minutes before treatment and approximately 5 minutes after treatment
Other outcomes:
Locations:
Study officials:
References: