Protocol summary

Summary
This study will be a single blind clinical trial. The study population included patients with cancer referred to chemotherapy will be 22 Bahman hospital in neyshabur. The sampling will be easy and accessible and Patients were randomly divided into intervention (55) and control (55 persons) groups.At the beginning of the study, the anxiety and depression levels of patients in both groups were measured by Beck anxiety and depression questionnaires. The intervention group will be asked to use chamomile tea once a day for 2 weeks. There is no intervention in the control group. After the intervention, both groups will fill the questionnaire mentioned.

General information

Acronym
Chamomile's Effect on Anxiety and Depression in Cancer Patients
IRCT registration information
IRCT registration number: IRCT2017101422218N3
Registration date: 2017-11-08, 1396/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Vahid Moeini Ghamchini
Name of organization / entity
Neyshabour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4062
Email address
v.moinighamchini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neyshabur University of Medical Sciences
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Chamomile on anxiety and depression in cancer patients treated with chemotherapy
Public title
The Effect of Chamomile tea on anxiety and depression in cancer patients treated with chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclussion Criteria: Diagnosis of cancer and chemotherapy ; Age between 18 to 65; Willingness to participate voluntarily in the study; The absence of mood disorder such as depression and anxiety previously known; Do not treat with psychosocial drugs; The condition of the patient be stable and the Oncology physician enters the patient into the study. Exclusion criteria: having reaction to Chamomile consumption; No tendency to continue the study; Patient death
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: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Postal code
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.NUMS.REC.1396.13

Health conditions studied

1

Description of health condition studied
cancer patients
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified

Primary outcomes

1

Description
depression and anxiety
Timepoint
two weeks
Method of measurement
beck questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive once in day for two weeks chamomile tea
Category
Treatment - Drugs

2

Description
There is no intervention in the control group for patients.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The chemotherapy department, 22 Bahman Neyshabur Hospital
Full name of responsible person
Vahid Moeini Ghamchini
Street address
City
Neyshabur

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
seyed reza mirhafez
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
Vahid Moeini Ghamchini
Position
Master of nursing/Faculty member
Other areas of specialty/work
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Postal code
Phone
+98 51 4225 4170
Fax
Email
v.moini@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
Vahid Moeini Ghamchini
Position
Master of nursing
Other areas of specialty/work
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Postal code
Phone
+98 51 4225 4170
Fax
Email
v.moini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
Vahid Moeini Ghamchini
Position
Master of nursing/ Faculty member
Other areas of specialty/work
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Postal code
Phone
+98 51 4225 4170
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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