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The Effect of Reflexology on Anxiety Symptoms, Pain Intensity and Sleep Quality in Breast Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial

Protocol summary

Study aim
Determining the effect of reflexology on anxiety symptoms, pain intensity, and sleep quality in breast cancer patients undergoing chemotherapy
Design
The present study is a parallel randomized clinical trial. Sixty breast cancer patients undergoing chemotherapy will be included in the study based on the inclusion and exclusion criteria and will be randomly assigned to intervention and control groups using quadruple blocks.
Settings and conduct
The study will take place at Loghman-e Hakim Hospital and Imam Hossein Hospital. In the intervention group, reflexology will be administered once a week for three weeks, with each session lasting half an hour. The control group will receive the usual care at the medical center. Data will be collected before the intervention and two weeks afterward.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive breast cancer diagnosis by a specialist physician, age above 18 years, and speaking Persian. Exclusion criteria: Received reflexology in the past, receiving radiation therapy as the first complementary treatment or concurrently, having any bleeding, seizures, or fever, having varicose veins and any foot disease, including open wounds or fractures, having any psychiatric disorder or dementia, male gender.
Intervention groups
In the intervention group, reflexology will be performed once a week for three weeks, with each session lasting half an hour and taking place after each chemotherapy session. The patient will be prepared, and their feet will be lubricated with sweet almond oil. The researcher will then conduct a relaxing massage on both feet 3-4 times for 10 minutes each, followed by a 20-minute session focusing on the treatment points on the soles of both feet. The control group will only receive the usual care provided by the treatment center.
Main outcome variables
Anxiety symptoms, pain intensity and sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231114060057N2
Registration date: 2024-10-17, 1403/07/26
Registration timing: prospective

Last update: 2024-10-17, 1403/07/26
Update count: 0
Registration date
2024-10-17, 1403/07/26
Registrant information
Name
Saeed Ghasempour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
saeed.ghasempoor@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Reflexology on Anxiety Symptoms, Pain Intensity and Sleep Quality in Breast Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial
Public title
The Effect of Reflexology on Anxiety Symptoms, Pain Intensity and Sleep Quality in Breast Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive breast cancer diagnosis by a specialist physician Age above 18 years Speaking Persian
Exclusion criteria:
Received reflexology in the past Receiving radiation therapy as the first complementary treatment or concurrently Having any bleeding, seizures, or fever Having varicose veins and any foot disease, including open wounds or fractures Having any psychiatric disorder or dementia Male gender
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be included in the study based on the inclusion and exclusion criteria through purposive sampling. They will then be randomly assigned to two groups: Group A (intervention) and Group B (control) based on quadruple blocks. The sequence of random allocation will be determined by SPSS software. With a sample size of 60 people, 15 quadruple blocks will be considered. Participants will be randomly assigned to their respective groups based on the order of entry into the study and the quadruple blocks.
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 Shahroud University of Medical Sciences
Street address
University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773943
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.SHMU.REC.1403.016

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Anxiety symptoms
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Generalized Anxiety Disorder Questionnaire

2

Description
Pain intensity
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Numerical Rating Scale

3

Description
Sleep quality
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, reflexology will be performed once a week for three weeks, with each session lasting half an hour and taking place after each chemotherapy session. The patient will be prepared, and their feet will be lubricated with sweet almond oil. The researcher will then conduct a relaxing massage on both feet 3-4 times for 10 minutes each, followed by a 20-minute session focusing on the treatment points on the soles of both feet.
Category
N/A

2

Description
Control group: The control group will only receive the usual care provided by the treatment center.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Haniyeh Ghanbarinasab
Street address
Iran, Tehran, Lashgar Intersection, Makhsous St, Loghman-e Hakim Hospital.
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Haniyeh Ghanbarinasab
Street address
Iran, Semnan, Shahroud, Imam St, End of Baghzindan 28 Meters, Imam Hossein Hospital.
City
Shahroud
Province
Semnan
Postal code
3616951835
Phone
+98 23 3234 2000
Email
imamhosein@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Behzad Garmabi
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
behzad.garmabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Saeed Ghasempour
Position
Reseacher
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
s.ghasempoor.2675@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Abbasi
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
abbasi_msn@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Saeed Ghasempour
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
s.ghasempoor.2675@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The demographic and clinical characteristics of the participants, as well as all information related to their anxiety symptoms, pain intensity, and sleep quality, can be shared while maintaining confidentiality and not using the names of the participants.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Project partners
Under which criteria data/document could be used
For people doing similar research work.
From where data/document is obtainable
The person in charge of the project should be contacted via email: abbasi_msn@yahoo.com
What processes are involved for a request to access data/document
Data will be provided to people through email.
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