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The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

Primary Purpose

Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who intended to undergo spinal surgery

Exclusion Criteria:

  • patients who does not speak Hebrew language

Sites / Locations

  • Meir MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy Group

control group

Arm Description

This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery

This group will not undergo any psychological intervention before the spinal surgery.

Outcomes

Primary Outcome Measures

BSI questionnaire in spine preoperative patients .
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
OSWESTRY questionnaire in spine preoperative patients
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
SF 36 questionnaire in spine preoperative patients
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
VAS scale in spine preoperative patients
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale

Secondary Outcome Measures

BSI questionnaire in spine postoperative patients
assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire
OSWESTRY questionnaire in spine postoperative patients
Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire
SF 36 questionnaire in postoperative patients
Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire
VAS scale in spine postoperative patients
Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale

Full Information

First Posted
June 8, 2014
Last Updated
March 14, 2016
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02237105
Brief Title
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
Official Title
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to examine the efficacy of Cognitive Behavioral Therapy (CBT) on the outcome of spinal surgery. The goal of this treatment is to change the coping style, thoughts, behavior and adaptive perception of the patient, and to replace them with an adaptive style. The patients in this study will be randomly divided into two groups. One group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery. The other group will be a control group, and will not have any psychological intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy Group
Arm Type
Experimental
Arm Description
This group will undergo Cognitive Behavioral Therapy (CBT) before having spinal surgery
Arm Title
control group
Arm Type
No Intervention
Arm Description
This group will not undergo any psychological intervention before the spinal surgery.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
BSI questionnaire in spine preoperative patients .
Description
assessment of emotional state in spine preoperative patients will be measured by analysis of BSI questionnaire
Time Frame
24 months
Title
OSWESTRY questionnaire in spine preoperative patients
Description
Assessment of disability in spine preoperative patients will be measured by analysis of OSWESTRY questionnaire
Time Frame
24 months
Title
SF 36 questionnaire in spine preoperative patients
Description
assessment of well being in preoperative patients will be measured by analysis of SF36 questionnaire
Time Frame
24 months
Title
VAS scale in spine preoperative patients
Description
Assessment of pain intensity in spine preoperative patients will be measured by analysis of VAS scale
Time Frame
24 months
Secondary Outcome Measure Information:
Title
BSI questionnaire in spine postoperative patients
Description
assessment of emotional state in spine postoperative patients will be measured by analysis of BSI questionnaire
Time Frame
24 months
Title
OSWESTRY questionnaire in spine postoperative patients
Description
Assessment of disability in spine postoperative patients will be measured by analysis of OSWESTRY questionnaire
Time Frame
24 months
Title
SF 36 questionnaire in postoperative patients
Description
Assessment of well being in spine postoperative patients will be measured by analysis of SF 36 questionnaire
Time Frame
24 months
Title
VAS scale in spine postoperative patients
Description
Assessment of pain intensity in spine postoperative patients will be measured by analysis of VAS scale
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who intended to undergo spinal surgery Exclusion Criteria: patients who does not speak Hebrew language
Facility Information:
Facility Name
Meir MC
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shushan Amir
Phone
09-7472966
Email
linor.amir@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Linor Shushan Amir, MA

12. IPD Sharing Statement

Learn more about this trial

The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery

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