Mental Health Interventions and Services will be studied on the side effects of Chemotherapy
Design
Control group clinical trial; With a randomized parallel group on 70 cancer patients
Settings and conduct
The field of study on cancer will be the research site of Baqiyatallah Hospital
Participants will be divided into experimental and control groups
The test group will be trained and given a guided audio file
The nausea and vomiting questionnaire will be completed before and after chemotherapy
Filling in the quality of life questionnaire pre-intervention and two months after the training will be done by two groups
Participants/Inclusion and exclusion criteria
Age above 18 and under 65 years; Minimum education level ; Willingness to participate in research ;nausea and vomiting experience in chemotherapy; not use nausea and vomiting medications other than routine And not using complementary medicines such as ginger; Failure to perform radiotherapy simultaneously with chemotherapy; No hearing disorders ; No history of gastrointestinal surgery; No history of gastrointestinal cancer; No history of mental disorder; No member in the health care team; Has not taken psychological skills training courses such as relaxation; And at least one course of chemotherapy is left after enrollment and is left at least one course of chemotherapy.
Intervention groups
The intervention group will be given a guided image during one hour of training and then during chemotherapy will hear the audio file guided by handsfree; to examine its effect on nausea and vomiting and quality of life ؛ in the control group to use handsfree only to prevent Listening to ambient noise will be done without listening to the audio file
Main outcome variables
frequency of Vomiting and Nausea, Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200710048073N1
Registration date:2021-02-27, 1399/12/09
Registration timing:prospective
Last update:2021-02-27, 1399/12/09
Update count:0
Registration date
2021-02-27, 1399/12/09
Registrant information
Name
Zahra Fereidouni Maman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4442 9249
Email address
zfreidon50@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the effects of Guided Imagery on Gastrointestinal complications and Quality of Life in Cancer patients undergoing Chemotherapy
Public title
The effect of Guided Imagery on Nausea and Vomiting and Quality of Life in Cancer Chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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.
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 Baqiyatallah University
Street address
Baqiyatallah University of Medical Sciences, Sheikh Baha'i St., Mulla Sadra St., Vanak, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.BMSU.REC.1399.462
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced Nausea and Vomiting in Cancer
ICD-10 code
C00-D49
ICD-10 code description
Neoplasms of unspecified behavior
2
Description of health condition studied
Quality of Life in Cancer patients undergoing Chemotherapy
ICD-10 code
C00-D49
ICD-10 code description
Neoplasms of unspecified behavior
Primary outcomes
1
Description
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
2
Description
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)
Secondary outcomes
1
Description
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 -
2
Description
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)
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Zahra Fereidouni Maman
Street address
Sheikh Baha'i Street ، Mulla Sadra Street,
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
zfreidon50@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alishiri Gholam Hossein
Street address
Sheikh Baha'i St., Mulla Sadra St., Vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 5250
Email
b.nehrir@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Khamseh Feryal
Position
MS in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences - Sheikh Baha'i St. - Mulla Sadra St. - Vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 5491
Fax
Email
khamseh_110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Batool Nehrir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences - Sheikh Baha'i St. - Mulla Sadra St. - Vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8755 5491
Email
rnehrir1739@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Zahra Fereidouni Maman
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18;Gulberg St., Park St, Hamila Blvd;Pounak
City
Tehran
Province
Tehran
Postal code
1469697413
Phone
+98 21 4442 9249
Email
zfreidon50@yahoo.com
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