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Trial registered on ANZCTR


Registration number
ACTRN12615000826549
Ethics application status
Approved
Date submitted
5/07/2015
Date registered
11/08/2015
Date last updated
11/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Eye Movement Desensitization and Reprocessing for postoperative pain management in adolescents
Scientific title
To investigate the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) for postoperative pain management in adolescents aged between 12 to 18.
Secondary ID [1] 286977 0
Nil
Universal Trial Number (UTN)
U1111-1171-5644
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain 295437 0
Condition category
Condition code
Mental Health 295689 295689 0 0
Studies of normal psychology, cognitive function and behaviour
Anaesthesiology 295938 295938 0 0
Pain management
Surgery 295939 295939 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An experimental, randomised controlled trial.
The Wong-Baker FACES Pain Rating Scale (WBFS) was first administered to all patients approximately 2 hours post-surgery, when each patient was reported to be conscious and alert. Participants also had their blood pressure and heart rate taken at this point. Participants were then taken to a private room, where they either underwent the EMDR or control condition activities. Following the administration of the WBFS, EMDR was administered to participants in the treatment group for 60 minutes.
EMDR therapy
EMDR therapy typically involves eight distinct phases: 1) Client history, 2) Preparation, 3) Assessment, 4) Desensitization, 5) Installation, 6) Body Scan, 7) Closure, and 8) Re-evaluation (Shapiro & Laliotis 2010). The first two stages are preparatory and primarily involve briefing the patient on the technique, as well as receiving relevant information regarding the patient’s history. The third stage (Assessment) centres around identifying negative and positive cognitions related to the trauma. It begins with identifying negative target memories for reprocessing, where participants are instructed to represent such memories as either a representative image or an associated negative cognition. In this experiment target cognitions comprised descriptions of negative beliefs associated with the surgery (e.g. ‘I am in danger’, or ‘It will be painful’) and/or negative images associated with the surgery (e.g. a visual representation of the surgical procedure). Participants were then instructed to form a positive cognition related to their target cognition/image. In this experiment participants were instructed to state how they would like to feel in words (e.g. ‘I am in control’ or ‘I am not in danger’) or using imagery (lying in bed, free of pain).
During the fourth and fifth stages (Desensitization and Installation), the negative cognition/image is recreated in the participant’s mind, and the patient is asked to track the therapist’s fingers, which are constantly displaced across the patient’s line of vision (Shapiro 1989). The speed of the eye movements is gradually increased until it is as fast as is comfortable for the client to maintain accurate tracking. During this process the patient is told to report any information that they become aware of, and once tracking is finished they are told to ‘let it go’ or ‘blank it out’ (Smith & Yule 1999, p. 269). This process is repeated until no further improvements occur. The positive cognition is then installed by having patients think of the negative event and positive cognition in parallel, whilst completing a further set of eye movements. This is repeated until patients have internalized the positive cognition, as indicated by the Validity of Cognition (VOC) scale (see Shapiro et al. 2010).
In the sixth stage (Body Scan), patients carry out a final set of eye movements, designed to target residual tension that occurs when participants are asked to again think of the original negative image/cognition. EMDR is only regarded as successful when participants can recall the initial image/cognition without experiencing body tension or pain. In the final two stages, Closure and Re-evaluation, participants are led through a range of relaxation exercises and debriefed. If participants require more than one session this is discussed in the final stage (Re-evaluation). In the current study patients all participated in only a single session. For a full overview of EMDR therapy, see Shapiro et al. (2010).

a psychologist who had training in EMDR administered the EMDR.
Intervention code [1] 292184 0
Rehabilitation
Intervention code [2] 292185 0
Treatment: Other
Comparator / control treatment
The control group were not administered EMDR, but were instead subjected to a range of carefully worded, emotionally neutral, open-ended interview questions over the 60-minute period. Questions specifically focused on patient history as well as some general questions about health beliefs. Participants in both conditions therefore had similar levels of interaction with health professionals following the surgery.
Control group
Active

Outcomes
Primary outcome [1] 295397 0
Postoperative pain intensity as assessed using the Wong-Baker FACES Pain Rating Scale (WBFS).
Timepoint [1] 295397 0
2 hours post-surgery

The the Wong-Baker FACES Pain Rating Scale (WBFS) was administered to all patients approximately 2 hours post-surgery (pre test), and then 3 hours post-surgery (post test).
Secondary outcome [1] 315510 0
Postoperative anxiety as measured using the State-Trait Anxiety Inventory (STAI).
Timepoint [1] 315510 0
2 hours post surgery
The State-Trait Anxiety Inventory was administered 2 hours post-surgery (pre test), and then 3 hours post-surgery (post test).

Eligibility
Key inclusion criteria
Adolescents age between 12 to 18, candidates for abdominal surgery at Alzahra hospital, Isfahan, Iran.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
chronic medical problems, such as epilepsy, asthma, diabetic mellitus and haematological problems, and also children with psychiatric problems, including mental retardation, depressive and bipolar disorders and any kinds of psychotic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/04/2013
Date of last participant enrolment
Anticipated
Actual
12/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 6998 0
Iran, Islamic Republic Of
State/province [1] 6998 0
Isfahan

Funding & Sponsors
Funding source category [1] 291536 0
University
Name [1] 291536 0
the Azad University of Khorasgan, Olum Tahghighat,
Country [1] 291536 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Ms Shahla Zamani
Address
The Azad University of Khorasgan, Olum Tahghighat, Korasgan, Isfahan, Iran.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 290215 0
Individual
Name [1] 290215 0
Dr Zahra Izadikhah
Address [1] 290215 0
The School of Psychology and Counselling, the University of Southern Queensland, 487/521-535 West Street, Toowoomba, Queensland, Australia. Post Code: 4350.
Country [1] 290215 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293076 0
the Azad University of Khorasgan, Olum e Tahghighat,
Ethics committee address [1] 293076 0
Ethics committee country [1] 293076 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 293076 0
Approval date [1] 293076 0
01/03/2013
Ethics approval number [1] 293076 0
48620701912004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58366 0
Dr Zahra Izadikhah
Address 58366 0
the School of Psychology and Counselling, The University of Southern Queensland, 487/521-535 West Street, Toowoomba, Queensland, Post Code: 4350.
Country 58366 0
Australia
Phone 58366 0
+61 403 007 963
Fax 58366 0
Email 58366 0
zahra.izadikhah@usq.edu.au
Contact person for public queries
Name 58367 0
Zahra Izadikhah
Address 58367 0
the School of Psychology and Counselling, The University of Southern Queensland, 487/521-535 West Street, Toowoomba, Queensland, Post Code: 4350.
Country 58367 0
Australia
Phone 58367 0
+61 403 007 963
Fax 58367 0
Email 58367 0
zahra.izadikhah@usq.edu.au
Contact person for scientific queries
Name 58368 0
Zahra Izadikhah
Address 58368 0
the School of Psychology and Counselling, The University of Southern Queensland, 487/521-535 West Street, Toowoomba, Queensland, Post Code: 4350.
Country 58368 0
Australia
Phone 58368 0
+61 403 007 963
Fax 58368 0
Email 58368 0
zahra.izadikhah@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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