Mindfulness-Based Analgesia or Placebo Effect? The Development and Evaluation of a Sham Mindfulness Intervention for Acute Experimental Pain.
Jonathan N. Davies, Louise Sharpe, Melissa A Day, Ben Colagiuri
Psychosomatic Medicine DOI: 10.1097/psy.0000000000000886 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 93 |
| Population | Healthy volunteers undergoing acute experimental heat pain |
| Interventions | Focused-attention mindfulness sham mindfulness |
| Duration | 6 × 20-minute sessions |
| Topics | Meditation |
| Key findings | Mindfulness and a closely matched sham mindfulness intervention both moderately increased pain tolerance relative to no treatment, with no difference between them, suggesting placebo effects contribute to pain tolerance changes after mindfulness training. Neither intervention reduced pain intensity or unpleasantness relative to no treatment, although mindfulness reduced unpleasantness relative to sham, offering limited evidence of a specific effect. |
Abstract
Meta-analyses indicate that mindfulness meditation is efficacious for chronic and acute pain, but most available studies lack active control comparisons. This raises the possibility that placebo-related processes may account, at least in part, for mindfulness effects. The objective of this study was to develop a closely matched sham mindfulness condition to establish whether placebo effects contribute to mindfulness-based interventions for pain. We developed and validated a closely matched sham mindfulness intervention then compared it with 6 × 20-minute sessions of focused-attention mindfulness and a no-treatment condition in 93 healthy volunteers undergoing acute experimental heat pain. The sham mindfulness intervention produced equivalent credibility ratings and expectations of improvement as the mindfulness intervention but did not influence mindfulness-related processes. In contrast, mindfulness increased "observing" relative to no treatment but not sham. Mindfulness (F(1,88) = 7.06, p = .009, ηp2 = 0.07) and sham (F(1,88) = 6.47, p = .012, ηp2 = 0.07) moderately increased pain tolerance relative to no treatment, with no difference between mindfulness and sham (F(1,88) = 0.01, p = .92, ηp2 < 0.001). No differences were found for pain threshold. Similarly, neither mindfulness nor sham reduced pain intensity or unpleasantness relative to no treatment, although mindfulness reduced pain unpleasantness relative to sham (F(1,88) = 5.03, p = .027, ηp2 = 0.05). These results suggest that placebo effects contribute to changes in pain tolerance after mindfulness training, with limited evidence of specific effects of mindfulness training on pain unpleasantness relative to sham, but not no treatment. To disentangle the specific analgesic effects of mindfulness from placebo-related processes, future research should prioritize developing and incorporating closely matched sham conditions.Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12618001175268).
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 11
- Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial. Pain October 1, 2023
- Pain, mindfulness, and placebo: a systematic review. Frontiers in Integrative Neuroscience 2024
- A randomized-controlled trial comparing relative effects of mindfulness-based interoceptive exposure focus versus distraction on cold-pressor induced pain. Behaviour Research and Therapy July 26, 2025
- The Impact of Understanding and Openness on State Mindfulness Following a Brief Meditation: A Sham Controlled Study Mindfulness August 1, 2025
- Combining mindfulness intervention and open-label placebo treatment for chronic pain: a protocol for a feasibility study. Pilot and Feasibility Studies August 20, 2025
and 6 more in the library
Cites 23
- Mindfulness training as a clinical intervention: A conceptual and empirical review. Clinical Psychology Science and Practice 2003
- Mindfulness Interventions Annual Review of Psychology September 30, 2016
- Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation Perspectives on Psychological Science October 10, 2017
- Conceptual and methodological issues in research on mindfulness and meditation. American Psychologist October 1, 2015
- What Do We Really Know About Mindfulness-Based Stress Reduction? Psychosomatic Medicine 2002
and 18 more in the library