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The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on Anxiety and Pain Levels Experienced by Hospitalized Children After Undergoing Surgery

Protocol summary

Study aim
Determining the Effect of Eye Movement Desensitization and Reprocessing on Hospitalized Children's Anxiety and Pain Levels
Design
Two-group clinical trial by random assignment.
Settings and conduct
This study will be conducted at The Imam Hussein Pediatric Hospital and at The Alzahra Medical Center for Children. The experimental group will undergo Eye Movement Desensitization and Reprocessing Therapy for one session, spanning in length from at least 30 to up to 60 minutes. Afterwards to evaluate the levels of anxiety and pain within the participants of the experimental group, Spielberg's State-Trait Anxiety Inventory and a basic numeric scale for pain will be administered. The control group will receive no special intervention other than being provided a training booklet. The control group will also be evaluated for pain and anxiety using a basic numeric scale for pain and Spielberg's State-Trait Anxiety Inventory. Measures for pain and anxiety will be recorded before intervention, immediately after the intervention and one hour post intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being between the ages of 12 to 16 years, having experienced hospital admission and surgery for the first time, having mental health and alertness. Non-entry criteria: undergoing other pharmacological interventions, having a history of major psychiatric illnesses, being under severe stress, taking pain and anxiety-reducing medications.
Intervention groups
The experimental/intervention group will undergo Eye Movement Desensitization and Reprocessing therapy, the control group will not receive an intervention.
Main outcome variables
Pain and anxiety

General information

Reason for update
Acronym
EMDR
IRCT registration information
IRCT registration number: IRCT20190925044880N1
Registration date: 2020-05-08, 1399/02/19
Registration timing: retrospective

Last update: 2020-05-08, 1399/02/19
Update count: 0
Registration date
2020-05-08, 1399/02/19
Registrant information
Name
Afarin Ghanavatpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 1793
Email address
a.ghanavatpoor@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on Anxiety and Pain Levels Experienced by Hospitalized Children After Undergoing Surgery
Public title
The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on Anxiety and Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being between the ages of 12 to 16 years old Experiencing hospital admission and surgery for the first time Being of sound mental health
Exclusion criteria:
No other non-pharmacological intervention to control pain and anxiety during research stages. The subjects have not undergone eye surgery, maxillofacial surgery, and neurosurgery. Absence of facial and facial nerves in a way that prevents eye movements. history of hyperactivity, depression, severe anxiety disorders, psychosis, and other major psychiatric illnesses- history of known chronic diseases such as disability, diabetes, heart disease, cancer Lack of speech abnormalities in a way that prevents the child from providing information and communication.- history of surgery Being under severe stress due to education, parental loss, divorce, etc taking anxiolytic and antidepressant drugs
Age
From 12 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of the samples, participants names are written on paper cards and then put in a box. ‎The names of participants are then randomly selected by the researcher. The first name drawn is assigned to the experimental group ‎and the second name is assigned to the control group, and so on until all of the cards are selected. In this way, ‎participants do not know whether they are in the experimental or control group.‎
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Building No.4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-09-22, 1398/06/31
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.372

Health conditions studied

1

Description of health condition studied
Children's Surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before Surgury,Before intervention, immediately and then one hour later. ‎
Method of measurement
Spielberger's State-Trait Anxiety ‎

2

Description
Pain
Timepoint
Before intervention, immediately and then one hour later. In the control group
Method of measurement
and numerical pain rating scale

Secondary outcomes

empty

Intervention groups

1

Description
The Spielberger State-Trait Anxiety ‎Inventory(STAI) is administered to subjects before and after surgery, in both the experimental and control groups. Along with the STAI used for anxiety measures, a numerical pain rating scale is utilized to evaluate levels of pain. In this experiment the patient will undergo EMDR therapy for one session, spanning from at least 30 minutes to up to 60 minutes. The patient will be asked to talk about his/her experiences with their illness and surgery; discussing their memories, worries and negative feelings related to these experiences. Subsequently, scores are obtained through two common methods of variable measurement associated with the practice of EDMR therapy. These methods include the Subjective Units of Disturbance (SUD) Scale, a numerical scale running from 1 through 10, commonly used in the practice of EDMR. The second mode of variable measurement is conducted through the Validity of Cognition (VOC) Scale, a numerical scale running from 1 through 7. These tests are administered to the patients via the researchers and the results are recorded. In the next phase of the experiment, the children are asked to imagine and describe somewhere they consider a safe place and that makes them feel most calm; this could include for example a beach, forest, their room, etc. The child is also asked to keep in mind his/her painful memories associated with all the unpleasant emotions regarding surgery and hospitalization that cause him or her distressing thoughts. At the same time, his/her eyes should be focused on the researcher's finger movements, this should result in them experiencing rapid eye movements synchronized with the movement of the researcher's finger. The treatment then switches focus to the child's positive beliefs and emotions, the child is encouraged through this therapy to replace their positive emotions with the negative beliefs they are harboring with them. This time, while visualizing and keeping the painful memory in mind, we ask the child to trust his/her positive beliefs, while simultaneously following the researcher's hand movements with his/her eyes. At the end of the treatment, we ask of the children to imagine themselves in that safe place they discussed at the beginning of the session. Following the completion of EDMR therapy, the VOC and SUD scores are once again recorded from the participants. The researchers then work with the children to navigate through their emotions, to relieve negative emotions they have been harboring, that are causing feelings of distress and helplessness. In addition, Spielberger Inventory and the numerical ‎pain rating scale are also once again administered and recorded, both immediately after treatment and one-hour post-treatment.
Category
Treatment - Other

2

Description
Control group: In the control group the Spielberger State-Trait Anxiety ‎Inventory(STAI) is initially administered to subjects at the beginning of the trial. The control group receives no intervention, other than being given a copy of the training booklet designed for them. The STAI is then administered and recorded two more times, the first and second hours post experiment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hussein pediatric hospital
Full name of responsible person
Mehrdad Memarzadeh
Street address
sfahan - km 10 Street Imam Khomeini - hospital Imam Hussein
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
Emamhossein_hospital@mui.ac.ir

2

Recruitment center
Name of recruitment center
Alzahra Medical Cente
Full name of responsible person
Majid Rezvani
Street address
Shahid Keshvari Highway - Safa Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Javanmard Haghju Shaghayegh Doctor
Street address
Three floor,Building No.4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3792 3061
Fax
Email
nrec@behdasht.gov.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afarin Ghanavatpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.36, Shahed Ave., Chaharbagh Bala Street., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8163673338
Phone
+98 31 3667 1793
Fax
Email
a.ghanavatpoor@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afarin Ghanavatpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.36, Shahed Ave., Chaharbagh Bala Street., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8163673338
Phone
+98 31 3667 1793
Fax
Email
a.ghanavatpoor@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Afarin Ghanavatpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.36, Shahed Ave., Chaharbagh Bala Street., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8163673338
Phone
+98 31 3667 1793
Fax
Email
a.ghanavatpoor@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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