Investigating the effect of hand reflexology on chemotherapy-induced nausea and vomiting in breast cancer patients
Design
The clinical trial has an intervention and control group, double-blinded and randomized, which will be conducted on patients with breast cancer undergoing chemotherapy
Settings and conduct
Chemotherapy often causes nausea and vomiting, requiring effective management. This study involves breast cancer patients undergoing chemotherapy at Imam Hossein Hospital, Torbat Heydariyeh. Participants are randomized in blocks of 4 into two groups. Reflexology will be performed for both groups immediately after chemotherapy, for four weeks. The double-blind trial applies similar interventions to both groups, with non-real points in controls and real points in the intervention group. Both patients and the administrator are blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Confirmed diagnosis of breast cancer and undergoing chemotherapy with drugs that have moderate to high emetogenic potential.
First cycle of chemotherapy.
Literacy.
No wounds on the hand area.
No use of antiemetic drugs other than those prescribed by the treating physician in the ward.
No history of diseases that cause vomiting, such as liver failure, gastrointestinal disorders, acute phase of hepatitis B and etc.
Exclusion Criteria: Not being in the first cycle of chemotherapy.
Presence of wounds or injuries on the hand area.
Presence of diseases leading to vomiting.
Intervention groups
In the intervention group, reflexology will be performed on points on the hand that are effective in reducing nausea and vomiting weekly for four weeks immediately after chemotherapy drug injection. In the control group, reflexology will be performed on points on the hand that are not effective in reducing nausea and vomiting.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190625044009N3
Registration date:2025-07-10, 1404/04/19
Registration timing:prospective
Last update:2025-07-10, 1404/04/19
Update count:0
Registration date
2025-07-10, 1404/04/19
Registrant information
Name
Mahla Rajabzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3601 6795
Email address
rajabzadehm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of hand reflexology on chemotherapy-induced nausea and vomiting in patients with breast cancer
Public title
The effect of hand reflexology on chemotherapy-induced nausea and vomiting
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of breast cancer and chemotherapy with drugs that are moderately to severely emetic
First course of chemotherapy
Being literate
No wounds on the hand
Do not use anti-nausea and anti-vomiting medications other than those prescribed in the ward by treating physician.
Not having diseases that can lead to vomiting, such as liver failure, kidney failure, digestive disorders, acute phase of hepatitis B, gastrointestinal obstruction and Brain tumor
Exclusion criteria:
Lack of willingness of research units to continue participating in the study
Needing intensive care
Having a wound on the hands
Change in chemotherapy drug protocols
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized blocks design with size 4 was used for randomization. A total number of 15 blocks of four were prepared. Then, the samples were assigned to intervention and control groups. A specific letter is assigned to each group to construct the allocation sequence (A: Intervention Group, B: control Group). The allocation sequence will then be generated using online methods (https://www.sealedenvelope.com/simple-randomiser/v1/lists) without individual intervention. Next, the sequence is written on the sheets and placed in sealed envelopes, respectively to conceal the allocation sequence and participants will receive envelopes in the order they enter the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention is performed similarly for both groups (control and intervention); however, the intervention points in the control group are applied at non-real points, while in the intervention group they are applied at real points. Therefore, the patients are unaware of which group they have been assigned to and are blinded to the type of intervention they receive.
Additionally, the individual responsible for administering the intervention opens the envelopes containing the randomized sequence based on their numbering and performs the intervention. This person is blinded to the type of intervention assigned to each group (control or intervention).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences
Street address
Torbat Heydariyeh University of Medical Sciences, Mehr Boulevard, Valiasr Town
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516160061
Approval date
2025-05-18, 1404/02/28
Ethics committee reference number
IR.THUMS.REC.1404.006
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Chemotherapy-induced nausea and vomiting
Timepoint
During each of the four weeks of treatment, immediately after the chemotherapy drug injection (pre-test) and 24 hours after the massage (post-test)
Method of measurement
Rhodes Index of Nausea and Vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher will first wash the hands with warm water and remove jewelry, including watches and rings. The patient will remain in a sitting position. The researcher will begin a general massage with his thumb, starting at the patient's left forearm, then moving to the wrist, palm, back of the hand, and finally the fingers. The massage will be repeated eight to ten times. After the general hand massage, four reflexology points will be used for stimulation. The reflexology points include pericardium 6 on the inner surface of the wrist, approximately two finger widths above the skin fold of the wrist, the small intestine located on the back of the hand, in the triangular space between the metacarpal bones of the thumb and index finger, pericardium 7 just above the first fold of the wrist, and pericardium 8 on the center of the palm, where the tip of the middle finger reaches when making a fist. The researcher will press each of the reflexology points with his thumb until the patient feels pressure but does not feel pain. The duration of the massage for each point is two minutes, for a total of 16 minutes for both hands.
Category
Treatment - Other
2
Description
Control group: Control group: First, the researcher washes the hands with warm water and removes jewelry, including watches and rings. The patient will remain in a sitting position. The researcher will start a general massage with his thumb and the patient's left forearm, then move to the wrist, palm, back of the hand, and finally the fingers. The massage will be repeated eight to ten times. After the general hand massage, four reflexology points will be used for stimulation. The reflex points include the hypothenar point located on the fleshy prominence of the palm and under the little finger, the base of the fourth finger located on the palm, just below the metacarpal joint of the ring finger, the inner edge of the wrist located on the inner (ulnar) side of the wrist, about 2 centimeters below the wrist crease, and the back of the hand between the third and fourth fingers located on the dorsal surface of the hand, in the hollow between the metacarpal bones of the ring and little fingers, about one-third of the way to the wrist. The researcher presses each reflexology point with his thumb until the patient feels pressure but no pain. The duration of the massage for each point is two minutes, for a total of 16 minutes for both hands.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Amir Sadeq Al-Husseini
Street address
Imam Hossein Hospital, 5th kilometer of Torbat Heydariyeh to Mashhad road
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9519140001
Phone
+98 51 5242 0000
Email
ihh@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Ahmadi Soleimani
Street address
Torbat Heydariyeh University of Medical Sciences, Mehr Boulevard, Valiasr Town
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516160061
Phone
+98 51 5242 1000
Email
thums_edu@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Namazinia
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Torbat Heydariyeh University of Medical Sciences, Mehr Boulevard, Valiasr Town
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516160061
Phone
+98 51 5242 1000
Email
mnamazi99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahla Rajabzadeh
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8916
Email
rajabzadehm951@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahla Rajabzadeh
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nasibeh School of Nursing and Midwifery, Vesal Street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8916
Email
rajabzadehm951@gmail.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
Currently, no decision has been made in this regard by the team