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Influence of rituals on open-label placebo effect in healthy volunteers

Open-label placebo administration, performing a ritual, and wellbeing in healthy participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000305921
Enrollment
101
Registered
2020-03-05
Start date
2020-03-13
Completion date
2021-05-28
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the role of rituals in open-label placebo effect. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on wellbeing and randomly assigned to one of three conditions: no-treatment control, placebo treatment, or placebo treatment taken performing a ritual procedure.

Interventions

Open-label placebo administration (2 placebo pills per day to take every morning, with or without a ritual procedure to perform when taking the pills) for 6 days compared to a no treatment control condition. Adherence will be assessed via self-report at follow-up after completion of the course of placebo pills (day 6). Participants in the 'placebo plus ritual' group will be given a ritual procedure to follow every time they take the pills (A sequence of actions to perform, including shaking the

Open-label placebo administration (2 placebo pills per day to take every morning, with or without a ritual procedure to perform when taking the pills) for 6 days compared to a no treatment control condition. Adherence will be assessed via self-report at follow-up after completion of the course of placebo pills (day 6). Participants in the 'placebo plus ritual' group will be given a ritual procedure to follow every time they take the pills (A sequence of actions to perform, including shaking the capsules, blowing on them, gently tapping three times with one's hand on their forehead, chest and abdomen- see below for the complete procedure). Participants in the 'placebo only' group will be told to take two pills every day at the same time, without further instructions. All participants will be provided with information about the placebo effect following the talking points outlined by Kaptchuk and colleagues (2010) - namely that placebos are powerful, can produce an automatic healing response, that positive expectations are not necessary but keeping an open mind is important, and that taking pills faithfully (i.e. adherence) is critical. Information and instructions will be provided to both groups during an initial half hour face-to-face research session. Information provision will take approximately 10 minutes. At the end of this session, after completing a baseline assessment, participants will be given lactose-filled vegetarian gelatin placebo capsules to take every morning for the next 6 days and instructions on how to take them. Ritual procedure (approx. 90 seconds to complete): - Wash your hands up to your wrists; - Get the container and some water to drink; - Find a quiet and comfortable place; - Open the container and pick an orange capsule and a pink capsule; - Hold them in the palm of your non-dominant hand, keeping the hand open; - Close both hands together, holding the capsules; - Shake your hands lightly three times; - Close your eyes and gently blow into your hands, on the capsules; - Open your eyes and release your hands; - Pick the orange capsule and take it with some water; - Take a deep inhale and slowly exhale; - Pick the pink capsule and take it with some water; - Close your eyes and with the index and middle fingers of your dominant hand: • Tap your forehead three times; • Tap your heart three times; • Tap your abdomen three times; - Merge your hands in front of your chest and bow your head; - Lift up.

Sponsors

Dr Kate Faasse
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants will be healthy undergraduate students seeking to improve well-being.

Exclusion criteria

Lactose intolerance

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026