]>
IRCT20190925044880N1 IRCT 2020-05-08 Esfahan University of Medical Sciences The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on Anxiety and Pain EMDR The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on Anxiety and Pain Levels Experienced by Hospitalized Children After Undergoing Surgery 2019-12-22 anticipated 56 Complete https://irct.ir/trial/42484 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.‎. N/A Children's Surgery. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no other information
public Afarin Ghanavatpoor
No.36, Shahed Ave., Chaharbagh Bala Street., Isfahan
Isfahan Iran (Islamic Republic of) 8163673338 +98 31 3667 1793 a.ghanavatpoor@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Afarin Ghanavatpoor
No.36, Shahed Ave., Chaharbagh Bala Street., Isfahan
Isfahan Iran (Islamic Republic of) 8163673338 +98 31 3667 1793 a.ghanavatpoor@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being between the ages of 12 to 16 years old Experiencing hospital admission and surgery for the first time Being of sound mental health 12 years 16 years Both 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 Treatment - Other Treatment - Other 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. 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. Anxiety. Timepoint: Before Surgury,Before intervention, immediately and then one hour later. ‎. Method of measurement: Spielberger's State-Trait Anxiety ‎. Pain. Timepoint: Before intervention, immediately and then one hour later. In the control group. Method of measurement: and numerical pain rating scale. Esfahan University of Medical Sciences Approved 2019-09-22 Ethics committee of Isfahan University of Medical Sciences Building No.4, Isfahan University of Medical Science, Hezarjirib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)