The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer in Amir Shiraz Hospital
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer
Design
A randomized clinical trial,with 72 samples,was administered to control and test groups,randomized block,one blinded
Settings and conduct
At Amir Hospital oncology in Shiraz,with training sessions and presentation of pamphlets,Only research samples are unaware of the allocation of study groups
Participants/Inclusion and exclusion criteria
Women aged 25 to 75 with colon cancer who are at stage 1, 2 and 3؛ who are aware of their illness and have minimal religious beliefs. women who are reluctant to engage in research or have severe physical or psychological problems not allowed
Intervention groups
First , after a course of chemotherapy ,questionnaires will distributed.Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group. And for the control group Only a series of training modules(educational pamphlets) in connection with spirituality-based palliative care are considered.The interval between chemotherapy courses is usually two weeks And every patient needs ten to twelve weeks of chemotherapy.The training program(The curriculum) consists of 6 sessions ,that each session takes an average of 2 hours.
Currently, this curriculum includes the following:first session: recitation of verses from Qur'an.second session: praying and discussing the psychological effects of praying.third session: Peer group discussions focused on relationship with God, Yourself ,others and nature.Fourth session: The Spiritual Authority 's Speech.fifth session: Play religious clips.sixth session: group praying.After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month
Main outcome variables
Pain score؛Quality of Life Score؛Nausea and Vomiting Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190106042252N1
Registration date:2019-01-27, 1397/11/07
Registration timing:registered_while_recruiting
Last update:2019-01-27, 1397/11/07
Update count:1
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
parisa sabetsarvestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3784 4396
Email address
123ps74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2019-02-02, 1397/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer in Amir Shiraz Hospital
Public title
The Effect of Palliative Care Based on Spirituality on Pain, Quality of Life and Nausea and Vomiting in Women with Colon Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are at stage 1 and 2 and 3 of their illness
Patients who are aware of their diagnosis
Patients who have at least one chemotherapy course
Patients at the minimum functional level
Age between 25 and 75 years
Complete mental health
Willingness to cooperate
Not suffering from other diseases except colon cancer
Having minimal spiritual beliefs
Lack of vision and hearing problems
عدم سابقه استفاده از مراقبت تسکینی مبتنی بر معنویت
Exclusion criteria:
Lack of cooperation
Occurs a particular physical condition
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In the sampling method, all available patients Enter the study.These patiens are assigned to the test and control group by Block randomization.
A: گروه کنترل
B: گروه آزمون
B(7) A(5) B(3) A(1)
B(8) A(6) A(4) B(2)
Then we randomize by Using 9 blocks of 8 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants are informed by informed consent and informed about the purpose of the study. However, they are not familiar with the control group or the test. Spirituality-based palliative care training sessions are held for the intervention group. In order to observe the intellectual property of the participants, the control group will be provided with a pediatric spirituality-based palliative care training package. All members are aware of the purpose of the study, and how they are done, but they are not informed about the two groups of control and test. So, the study is mono-blind, and researcher, clinical caregiver and data analyst are aware of the allocation of control and test groups. For Examples of mental health counselors, nutritionists, pain specialists, clerks, and final data analyst are known from the control and test team members, but participants do not know which groups will be included.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ebnesina square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2018-11-11, 1397/08/20
Ethics committee reference number
IR.FUMS.REC.1397.095
Health conditions studied
1
Description of health condition studied
colon cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
Pain score in Short Pain Questionnaire(BPI)
Timepoint
Measuring the pain before and after intervention and one month after the intervention
Method of measurement
Short Pain Questionnaire (Brief Pain Inventory)
2
Description
Quality of Life Score in World Health Organization Quality of Life Questionnaire
Timepoint
Measuring the quality of Life before and after intervention and one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire((WHOQOL-BREF)
3
Description
Nausea and vomiting score in the questionnaire for measurement of nausea and vomiting, Korn et al
Timepoint
Measuring the nausea and vomiting before and after intervention and one month after the intervention
Method of measurement
Questionnaire for measurement of nausea and vomiting by Korn et al (PUQE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First , after a course of chemotherapy ,questionnaires will distributed between 36 member of the intervention group .Then at the time of the referral of patients for the next chemotherapy course ,Training program begins for the exam group.The interval between chemotherapy courses is usually two weeks . And every patient needs ten to twelve weeks of chemotherapy , depending on the severity of the patient's disease and physician's discretion.The training program(The curriculum) consists of 6 sessions ,that each session takes an average of 2 hours.Currently, this curriculum includes the following:first session: recitation of verses from Qur'an. second session: praying and discussing the psychological effects of praying. third session: Peer group discussions focused on God ,relationship with Yourself ,others and nature. Fourth session: The Spiritual Authority 's Speech. fifth session: Play religious clips sixth session: group praying .After completing the training course and in the last session ,The questionnaires will be distributed immediately and after a month. The intervention group may be divided into two groups of 18 member During interventions.
Category
Rehabilitation
2
Description
Control group: First, after completing a chemotherapy course, questionnaires are distributed among the control group members.Then, after the last session of the intervention group, the control group will receive only a series of educational pamphlets related to spirituality-based relief care after completing their chemotherapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir oncology hospital
Full name of responsible person
parisa sabet sarvestani
Street address
Farhang shahr, Rajaei Blvd, infront of Kowsar Water Park
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Parisa Sabetsarvestani
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.599, emam khomeini street, 22 alley
City
Sarvestan
Province
Fars
Postal code
7345187749
Phone
+98 71 3784 4396
Fax
Email
123ps74@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The final data of the study is after statistical analysis and the results are comparable.
Access to questionnaires and informed consent form is not permitted.
When the data will become available and for how long
2 months after the final release of the results
To whom data/document is available
Researchers working in academic and scientific institutions and hospital staff
Under which criteria data/document could be used
All clinics that are responsible for caring for patients with colon cancer can use this research to care for patients.
It can also be used for other research on palliative care. The right to use the names of patients, the forms of consent to participate in the research.
From where data/document is obtainable
Parisa sabet sarvestani- 09171898537-123ps74@gmail.com
Dr shahnaz karimi-09173310457-sh.karimi16@yahoo.com
Fasa University of Medical Sciences- research@fums.ac.ir
What processes are involved for a request to access data/document
Search the title of research on valid sites
calling the responsible person
Email to Fasa University of Medical Sciences