Protocol summary

Study aim
Determining the effect of color therapy on the anxiety of chemotherapy patients referred to the oncology department
Design
A clinical trial with two control and intervention groups, with parallel groups, one blind strain, randomization using a random number table, with a number of 189 samples.
Settings and conduct
In this study, 189 patients referred for chemotherapy to the chemotherapy department of Bistoon Hospital are studied. Both intervention and control groups are given the Beck questionnaire to measure anxiety, and after filling it and using a table of random numbers, randomization is done and for blinding, the study subjects are blinded from the corridor inside the room. and the intervention group was transferred to a private room with a blue color spectrum and the control group was transferred to a normal room with the normal color spectrum of the hospital and they stayed in that environment for twenty minutes. Then again, the anxiety level of people in both groups is measured by Beck's questionnaire.
Participants/Inclusion and exclusion criteria
Conducting at least one chemotherapy session and being hospitalized for more than 6 hours for chemotherapy and willingness to participate in the study are the entry criteria and unwillingness to participate in the study or not completing the questionnaire completely are the criteria for excluding people from the research.
Intervention groups
Both the intervention and control groups will be given the Beck questionnaire to measure anxiety and after filling it, the intervention group will be transferred to a private room with a blue color spectrum, and the control group will be transferred to a normal room with the usual color spectrum of the hospital and spend twenty minutes in that environment. As. Then again, the anxiety level of people in both groups is measured by the Beck questionnaire.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130603013568N8
Registration date: 2023-04-24, 1402/02/04
Registration timing: registered_while_recruiting

Last update: 2023-04-24, 1402/02/04
Update count: 0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Rostam Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 6613
Email address
rjalali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Color Therapy on patient’s anxiety under chemotherapy in oncology unit:A Randomized Clinical Trial study
Public title
Effects of Color Therapy on patient’s anxiety under chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Do at least one chemotherapy session Hospitalization for more than 6 hours for chemotherapy Willingness to participate in the study
Exclusion criteria:
Unwillingness to participate in the study Failure to fully complete the questionnaire
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 189
Randomization (investigator's opinion)
Randomized
Randomization description
It will be simple randomization with random assignment to intervention and control groups and using a table of random numbers from top to bottom. First, the patients in the study are placed in the waiting room and are registered by the researcher, then the researcher moves from top to bottom by using the table of random numbers and in order to allocation Concealmen the numbers are written on a card and the cards are placed in the letter envelopes in order. In order to preserve the random sequence, the pass number is done in the same order on the outer surface of the envelopes. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group will participate. Each sample will be assigned a number. The study subjects are divided into two groups of 95 people (total study 189 people) A and B, the even numbers of group A, which is the intervention group, and the odd numbers of group B, which is the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding is done in a one-way blind method, in such a way that after registering and assigning an envelope to them, in order to determine the intervention or control group, according to the number in the envelope, the subjects left the waiting room. He/She passed through the rooms and if the number inside the envelope seen by the researcher is an even number, the person in question will go to the intervention room, and if the number is odd, the sample will go to the control room.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.KUMS.REC.1401.553

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Beck's Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group: First, they fill out the Beck questionnaire, then they are transferred to one of the two private rooms of the ward through a corridor that is not clear inside the rooms, these rooms are blue in color with blue light, blue bedspread, blue pillowcase and blue blanket. , the curtain around the bed is blue, the lacquer is blue, and the flowers are blue, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured.
Category
Behavior

2

Description
Control group:First, they fill out the Beck questionnaire, then they are transferred to one of the common rooms of the ward through a corridor that is not clear inside the rooms, which are white with the usual color range of the ward, and have moonlight, white bedding, The white pillowcase and blanket, the curtain around the bed is green, the lacquer is green, and they stay in this room for 20 minutes, and then Beck's questionnaire is given to them and the level of anxiety is measured.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bistoon hospital
Full name of responsible person
Shahin Panahi
Street address
126 Alley,Hashem Azadi Street,Amjadian Blv.
City
Kermanshah
Province
Kermanshah
Postal code
6717748985
Phone
+98 83 3431 8417
Email
shahinpanahi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Vice Research and Technology Affair, No 2 Building, Shahid Beheshti Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8259
Email
daftarriasat@Kums.ac.ir
Web page address
http://www.Kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department ,Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
َAssociate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
For keeping anonymous
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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