NCT00521807

Brief Summary

Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP). Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
Last Updated

October 20, 2008

Status Verified

August 1, 2007

First QC Date

August 27, 2007

Last Update Submit

October 17, 2008

Conditions

Keywords

Hypnosis,Chronic widespread pain,CWP,General Practice

Study Arms (2)

A 1

NO INTERVENTION

A 2

EXPERIMENTAL

Treatment group

Procedure: Hypnosis

Interventions

HypnosisPROCEDURE

a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week,

A 2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic widespread pain for at least three months and at most five years.

You may not qualify if:

  • Patients having primarily other organic diseases or serious psychiatric disorders were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1) Institute of General Practice and Community Medicine, University of Oslo

Oslo, 0318, Norway

Location

Related Publications (1)

  • Grondahl JR, Rosvold EO. Hypnosis as a treatment of chronic widespread pain in general practice: a randomized controlled pilot trial. BMC Musculoskelet Disord. 2008 Sep 18;9:124. doi: 10.1186/1471-2474-9-124.

MeSH Terms

Conditions

Chronic Pain

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan R Grondahl, Dr

    The Institute of General Practice and Community Medicine, University of Oslo, Norway.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Study Start

March 1, 2001

Study Completion

May 1, 2005

Last Updated

October 20, 2008

Record last verified: 2007-08

Locations