COping With PAin Through Hypnosis, Mindfulness & Spirituality

Status Not yet recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04491630
Study type	Interventional
Source	ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Contact	Alexandra Ferreira-Valente, PhD
Phone	+351969082988
Email	mafvalente@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 2020
Completion date	March 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Recruiting	`NCT06350084` - Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection	N/A
Completed	`NCT04080037` - Assessing Opioid Care Practices Using CPV Patient Simulation Modules	N/A
Recruiting	`NCT05458037` - RCT of Pain Perception With Fast and Slow Tenaculum Application	N/A
Completed	`NCT04571515` - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain	Phase 2
Recruiting	`NCT06005480` - Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers	Phase 1
Active, not recruiting	`NCT04850079` - EHR Precision Drug Treatment in Neonates
Completed	`NCT03272139` - Interscalene Block Versus Superior Trunk Block	Phase 4
Completed	`NCT03271151` - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty	Phase 4
Recruiting	`NCT05383820` - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment	Phase 4
Completed	`NCT04851353` - Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures	N/A
Completed	`NCT03280017` - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain	Phase 4
Completed	`NCT04280796` - Changes in Affective Pain Processing in Human Volunteers	N/A
Not yet recruiting	`NCT04523623` - Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries	N/A
Not yet recruiting	`NCT04062513` - Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response	N/A
Withdrawn	`NCT03137017` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults	Phase 1
Withdrawn	`NCT03137030` - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults	Phase 1
Completed	`NCT04659395` - How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block	N/A
Recruiting	`NCT03257319` - Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department	Phase 3
Recruiting	`NCT05095025` - PENG: an Estimation of ED50 in Neck of Femur Fracture	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

COping With PAin Through Hypnosis, Mindfulness and Spirituality — COPAHS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms