COping With PAin Through Hypnosis, Mindfulness and Spirituality

NCT04491630 | Unknown

• 1 other identifier: ISPA
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Acute

Keywords

Experimental pain; Self-hypnosis; Mindfulness meditation; Christian prayer

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity

  0-10 Numerical Rating Scale

  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

  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)

  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)

  Pre-treatment (collected up to 30 minutes before intervention), and post-treatment (collected up to 30 minutes after intervention)

Other Outcomes (6)

• Hypnotic suggestibility

  Baseline

• Baseline mindfulness

  Baseline

• Acceptance

  Baseline

Study Arms (4)

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.

Interventions

Self-Hypnosis (SH) BEHAVIORAL

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).

Self-Hypnosis (SH)

Mindfulness Meditation (MM) BEHAVIORAL

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.

Mindfulness meditation (MM)

Christian Prayer (CP) BEHAVIORAL

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.

Christian prayer (CP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead

Study Sites (1)

ISPA

Lisbon, 1149-041, Portugal

Location

Related Publications (2)

• 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.

  PMID: 36582659 DERIVED

• Ferreira-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.

  PMID: 33558346 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Hypnosis; Mindfulness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Behavior Therapy

Central Study Contacts

Alexandra Ferreira-Valente, PhD

CONTACT

+351969082988; mafvalente@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and the experimenter who will conduct assessments and administer the audio-recorded interventions will be blind to the condition to which subjects will be assigned and to the study hypotheses. During informed consent, prospective participants will be told that they will listen to an audio-recording that previous research found to be helpful to pain management, and that the purpose of the study is to assess this the effects of this audio-recording on discomfort associated with the sensation of coldness. Participants will also be instructed not to disclose details of the content of the audios they receive to the experimenter. The research staff member responsible for participants' randomization will be blind to identifying information and to the code identifying each condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)