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IRCT20200710048073N1 IRCT 2021-02-27 Bagheiat-allah University of Medical Sciences The effect of Guided Imagery on Nausea and Vomiting and Quality of Life in Cancer Chemotherapy Exploring the effects of Guided Imagery on Gastrointestinal complications and Quality of Life in Cancer patients undergoing Chemotherapy 2021-02-28 anticipated 70 Complete https://irct.ir/trial/50696 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Considering that the research will be a clinical trial, it consists of two conditions; namely the intervention and random allocation. As a result, the sampling method is firstly based on the criteria of entering the target sampling method and then random allocation with quadruple blocks will be performed in two groups of intervention and control. The random characteristic method with quadratic blocks includes assignments of the intervention group A and to the observation group B. Six conditions of AABB، BBAA، ABAB، BABA، ABBA، BAAB, will be written separately and then will be thrown inside the container. One piece of paper will be randomly removed from the container, followed by writing down the condition. Then, the paper will be taken back into the container. Driven by the sample size, which is 70 patients, this operation will be repeated 15 times. Each time, the condition will be written in order. Each letter is allocated to a number from one to seventy. Each letter is placed in a matte envelope and numbers 1 to 70 are written on the envelope. Each time the disease is selected, one of these envelopes will be opened following the order written on the envelope and will be specified in the group in which the patient should be placed. N/A Condition 1: Chemotherapy-induced Nausea and Vomiting in Cancer. Condition 2: Quality of Life in Cancer patients undergoing Chemotherapy. Intervention 1: The intervention group will be given a Guided Imagery instruction by the researcher during one hour, then the audio file prepared by the researcher will be provided to the intervention group via WhatsApp to listen during Chemotherapy with handsfree. Approximate time to hear the audio file is about 20 minutes. Then people will be asked to listen to an audio file once a day for two months after this Chemotherapy. Intervention 2: The control group will be prevented from hearing environmental noise, by placing handsfree in their ears. On the other hand, they will not receive the audio file of the intervention group. 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 more information
public Khamseh Feryal
Baqiyatallah University of Medical Sciences - Sheikh Baha'i St. - Mulla Sadra St. - Vanak
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 5491 khamseh_110@yahoo.com Bagheiat-allah University of Medical Sciences scientific Batool Nehrir
Baqiyatallah University of Medical Sciences - Sheikh Baha'i St. - Mulla Sadra St. - Vanak
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8755 5491 rnehrir1739@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age above 18 years and under 65 years Minimum Education Level Willingness to participate in research Nausea and Vomiting experience during the Chemotherapy At least one session of Chemotherapy is performed and at least one course of Chemotherapy has left after enrollment 18 years 65 years Both Use of Nausea and Vomiting Medications other than routine and use of Complementary Medications such as Ginger Gastrointestinal Cancer Performing Radiotherapy simultaneously with Chemotherapy Hearing disorders History of Gastrointestinal Surgery Gastrointestinal Cancer History of mental disorder The participant is a member of the Healthcare team Have taken psychological skills training courses such as relaxation C00-D49 C00-D49 Neoplasms of unspecified behavior Neoplasms of unspecified behavior Rehabilitation Rehabilitation The intervention group will be given a Guided Imagery instruction by the researcher during one hour, then the audio file prepared by the researcher will be provided to the intervention group via WhatsApp to listen during Chemotherapy with handsfree. Approximate time to hear the audio file is about 20 minutes. Then people will be asked to listen to an audio file once a day for two months after this Chemotherapy. The control group will be prevented from hearing environmental noise, by placing handsfree in their ears. On the other hand, they will not receive the audio file of the intervention group. Nausea and Vomiting. Timepoint: Pre-intervention، post-intervention and two months after the intervention. Method of measurement: Nausea and Vomiting Questionnaire (The Multinational Association of Supportive Care in Cancer. Quality of Life. Timepoint: Pre-intervention and two months after the intervention. Method of measurement: Quality of Life Questionnaire - ( European Organization for Research and Treatment of Cancer). Nausea and Vomiting. Timepoint: Pre-intervention and after Chemotherapy and two months after the intervention. Method of measurement: Questionnaire Antiemesis Tool- The Multinational Association of Supportive Care in Cancer -. Quality of Life. Timepoint: Pre-intervention and two months after the intervention. Method of measurement: Quality of Life Questionnaire - ( European Organization for Research and Treatment of Cancer). Bagheiat-allah University of Medical Sciences Approved 2020-11-22 Ethics Committee of Baqiyatallah University Baqiyatallah University of Medical Sciences, Sheikh Baha'i St., Mulla Sadra St., Vanak, Tehran Tehran Tehran Iran (Islamic Republic of)