Pain, AcuteCOPAHSNCT04491630
COping With PAin Through Hypnosis, Mindfulness and Spirituality
A study testing Self-Hypnosis (SH), Mindfulness Meditation (MM) and Christian Prayer (CP) in people with Pain, Acute, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
Trial summary
The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Self-Hypnosis (SH), Mindfulness Meditation (MM) and Christian Prayer (CP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2020to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older;
- able to read, speak and understand Portuguese;
- willing to be randomly assigned to all four conditions (regardless of participant's own religious affiliation)
Who cannot join
- reporting history of musculoskeletal problems, cancer, heart disease, stroke, epilepsy, diabetes, or Raynaud syndrome;
- having an open wound, cut, or fracture in any of the upper limbs;
- self-reported alcohol or substance dependence;
- cognitive or physical impairment, or severe psychopathology that could prevent participation.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
ISPA
Lisbon, 1149-041
Alexandra Ferreira-Valente, PhD, 969082988, mafvalente@gmail.com
Alexandra Ferreira-Valente, PhD
About this study
The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.
Read the detailed description
The primary aim of this study (Aim 1) is to compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers.
An exploratory aim of this study (Aim 2) is to identify possible shared and unique predictors of response to the three treatment conditions. The possible predictors we plan to test include sex, age, religious affiliation, hypnotic suggestibility, baseline mindfulness, acceptance, pain-related beliefs, religiosity, trait spirituality, previous experience with SH, MM and CP, outcome expectancies, and trait absorption.
This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points: baseline (T0), pre-test (T1), and post-test (T2). Eligible healthy adults will be randomized to one of the four study conditions. Interventions will be a 20-minutes audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minutes audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minutes recording of a natural history textbook. Primary outcomes are pain intensity, pain tolerance, and pain-related stress as measured by salivary cortisol level and heart rate variability.
- Conditions
- Pain, Acute
- Being tested
- Self-Hypnosis (SH), Mindfulness Meditation (MM), Christian Prayer (CP)
- Keywords
- Experimental pain, Self-hypnosis, Mindfulness meditation, Christian prayer
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Hypnosis (SH)Behavioural
Participants assigned to this condition will listen to a 20-minute recording with instructions of SH adapted from one of our team member's proposed model. First, the audio recording will introduce and orient the participant to SH. Then instruction in SH will be provided, including: (a) how to self-induce a hypnotic induction; (b) specific self-suggestions for comfort and ability to manage intense sensations; and (c) post-hypnotic suggestions that the participant will be easily able to use these hypnotic strategies on their own at a later time (i.e., in this case, during the Cold Pressor Arm Wrap procedures that will follow).
A second 5-minute audio recording with instructions to guide the participant in SH will be provided during the second cycle of Cold Pressor Arm Wrap (CPAW).
Mindfulness Meditation (MM)Behavioural
Participants in the MM condition will listen to a 20-minutes recording with instructions in the use and application of Vipassana MM, adapted from the manual developed by one of our team members. First, the audio recording will focus on introducing the idea of attention to their breath, and of non-judgmental monitoring and acceptance of the all events and stimuli. Then a guided MM (body scan) experience will be provided.
A second 5-minute audio recording with instructions to facilitate the MM (body scan) experience taught in the first audio recording will be provided during the second cycle of CPAW.
Christian Prayer (CP)Behavioural
Participants in this condition will listen to a 20-minute recording with CP instructions. These instructions will be adapted from the existing on-line biblical meditations from the Society of Jesus (www.passo-a-rezar.net). First, the recording will introduce and orient the participant to CP. Then, a text of the Bible will be read twice, followed by a brief suggestion of prayer.
A second 5-minute audio recording with instructions to facilitate the CP experience taught in the first audio recording, including the recording of a text of the Bible followed by a brief suggestion of meditation and relaxing music, will be provided during the second cycle of CPAW.
| Study group | Role | What they receive |
|---|---|---|
| Self-Hypnosis (SH) | Active comparator | Not described Receives: Behavioral: Self-Hypnosis (SH) |
| Mindfulness meditation (MM) | Active comparator | Not described Receives: Behavioral: Mindfulness Meditation (MM) |
| Christian prayer (CP) | Active comparator | Not described Receives: Behavioral: Christian Prayer (CP) |
| Control condition (CN) | No intervention | Participants in the CN condition will not be instructed to use any particular coping strategy to cope with the painful stimulation provided by the Cold Pressor Arm Wrap. Participants in the CN condition will listen to a 20-minute natural history audio recording. The option for this recording is supported by: (a) previous research showing that individuals who were asked to listen to it found it to be a neutral, yet relaxing, passage; (b) the use of this passage as an effective control condition in previous studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
0-10 Numerical Rating Scale
Measured: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Change in Pain Tolerance
Length (in seconds) that an individual bears painful stimulation
Measured: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Secondary outcomes (2)
Change in Pain-related stress (Heart rate)
Heart rate
Measured: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Change in Pain-related stress (Salivary cortisol level)
Salivary cortisol level
Measured: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized 4-group, 196-subject experimental mixed-model repeated-measures study to: 1. compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers; 2. to identify possible shared and unique predictors of response to the three treatment conditions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Alexandra Ferreira Valente, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491630
- Sponsor's protocol ID
- ISPA
- Acronym
- COPAHS
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira-Valente A, Van Dyke BP, Day MA, Teotonio do Carmo C, Pais-Ribeiro J, Pimenta F, Costa RM, Jensen MP. Immediate Effects of Hypnosis, Mindfulness Meditation, and Prayer on Cold Pressor Outcomes: A Four-Arm Parallel Experimental Study. J Pain Res. 2022 Dec 23;15:4077-4096. doi: 10.2147/JPR.S388082. eCollection 2022.
PubMed 36582659Ferreira-Valente A, Pimenta F, Costa RM, Day MA, Pais-Ribeiro J, Jensen MP. COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults. BMJ Open. 2021 Feb 8;11(2):e040068. doi: 10.1136/bmjopen-2020-040068.
PubMed 33558346
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COping With PAin Through Hypnosis, Mindfulness and Spirituality
- ClinicalTrials.gov ID
- NCT04491630
- Acronym / sponsor ID
- COPAHS / ISPA
- Conditions
- Pain, Acute
- Keywords
- Experimental pain, Self-hypnosis, Mindfulness meditation, Christian prayer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation.
Detailed description
The primary aim of this study (Aim 1) is to compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers.
An exploratory aim of this study (Aim 2) is to identify possible shared and unique predictors of response to the three treatment conditions. The possible predictors we plan to test include sex, age, religious affiliation, hypnotic suggestibility, baseline mindfulness, acceptance, pain-related beliefs, religiosity, trait spirituality, previous experience with SH, MM and CP, outcome expectancies, and trait absorption.
This is a randomized quantitative experimental mixed-model repeated-measures study with three assessment points: baseline (T0), pre-test (T1), and post-test (T2). Eligible healthy adults will be randomized to one of the four study conditions. Interventions will be a 20-minutes audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minutes audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minutes recording of a natural history textbook. Primary outcomes are pain intensity, pain tolerance, and pain-related stress as measured by salivary cortisol level and heart rate variability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized 4-group, 196-subject experimental mixed-model repeated-measures study to: 1. compare the immediate effects of self-hypnosis (SH), mindfulness meditation (MM), and Christian meditation (CM), relative to a control group (CN), for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation in a sample of healthy volunteers; 2. to identify possible shared and unique predictors of response to the three treatment conditions.
| Arm | Type | Receives |
|---|---|---|
| Self-Hypnosis (SH) | Active comparator | Behavioral: Self-Hypnosis (SH) |
| Mindfulness meditation (MM) | Active comparator | Behavioral: Mindfulness Meditation (MM) |
| Christian prayer (CP) | Active comparator | Behavioral: Christian Prayer (CP) |
| Control condition (CN) | No intervention | –Participants in the CN condition will not be instructed to use any particular coping strategy to cope with the painful stimulation provided by the Cold Pressor Arm Wrap. Participants in the CN condition will listen to a 20-minute natural history audio recording. The option for this recording is supported by: (a) previous research showing that individuals who were asked to listen to it found it to be a neutral, yet relaxing, passage; (b) the use of this passage as an effective control condition in previous studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older;
- able to read, speak and understand Portuguese;
- willing to be randomly assigned to all four conditions (regardless of participant's own religious affiliation)
Key exclusion criteria (4 listed)
- reporting history of musculoskeletal problems, cancer, heart disease, stroke, epilepsy, diabetes, or Raynaud syndrome;
- having an open wound, cut, or fracture in any of the upper limbs;
- self-reported alcohol or substance dependence;
- cognitive or physical impairment, or severe psychopathology that could prevent participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Hypnosis (SH)Participants assigned to this condition will listen to a 20-minute recording with instructions of SH adapted from one of our team member's proposed model. First, the audio recording will introduce and orient the participant to SH. Then instruction in SH will be provided, including: (a) how to self-induce a hypnotic induction; (b) specific self-suggestions for comfort and ability to manage intense sensations; and (c) post-hypnotic suggestions that the participant will be easily able to use these hypnotic strategies on their own at a later time (i.e., in this case, during the Cold Pressor Arm Wrap procedures that will follow). A second 5-minute audio recording with instructions to guide the participant in SH will be provided during the second cycle of Cold Pressor Arm Wrap (CPAW). | Behavioural | Self-Hypnosis (SH) |
| Mindfulness Meditation (MM)Participants in the MM condition will listen to a 20-minutes recording with instructions in the use and application of Vipassana MM, adapted from the manual developed by one of our team members. First, the audio recording will focus on introducing the idea of attention to their breath, and of non-judgmental monitoring and acceptance of the all events and stimuli. Then a guided MM (body scan) experience will be provided. A second 5-minute audio recording with instructions to facilitate the MM (body scan) experience taught in the first audio recording will be provided during the second cycle of CPAW. | Behavioural | Mindfulness meditation (MM) |
| Christian Prayer (CP)Participants in this condition will listen to a 20-minute recording with CP instructions. These instructions will be adapted from the existing on-line biblical meditations from the Society of Jesus (www.passo-a-rezar.net). First, the recording will introduce and orient the participant to CP. Then, a text of the Bible will be read twice, followed by a brief suggestion of prayer. A second 5-minute audio recording with instructions to facilitate the CP experience taught in the first audio recording, including the recording of a text of the Bible followed by a brief suggestion of meditation and relaxing music, will be provided during the second cycle of CPAW. | Behavioural | Christian prayer (CP) |
Primary outcome
Change in Pain Intensity
Time frame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
0-10 Numerical Rating Scale
Change in Pain Tolerance
Time frame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Length (in seconds) that an individual bears painful stimulation
2 secondary outcomes
Change in Pain-related stress (Heart rate)
Time frame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Change in Pain-related stress (Salivary cortisol level)
Time frame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 36582659Ferreira-Valente A, Van Dyke BP, Day MA, Teotonio do Carmo C, Pais-Ribeiro J, Pimenta F, Costa RM, Jensen MP. Immediate Effects of Hypnosis, Mindfulness Meditation, and Prayer on Cold Pressor Outcomes: A Four-Arm Parallel Experimental Study. J Pain Res. 2022 Dec 23;15:4077-4096. doi: 10.2147/JPR.S388082. eCollection 2022.
- Derived from this study: PubMed 33558346Ferreira-Valente A, Pimenta F, Costa RM, Day MA, Pais-Ribeiro J, Jensen MP. COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults. BMJ Open. 2021 Feb 8;11(2):e040068. doi: 10.1136/bmjopen-2020-040068.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Hypnosis (SH), Mindfulness Meditation (MM) and Christian Prayer (CP) in people with Pain, Acute, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Ferreira-Valente, PhD (+351969082988, mafvalente@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491630, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.