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IRCT20190625044009N3 IRCT 2025-07-10 Torbate-Heidaria University of Medical Sciences The effect of hand reflexology on chemotherapy-induced nausea and vomiting Determining the effect of hand reflexology on chemotherapy-induced nausea and vomiting in patients with breast cancer 2025-08-23 anticipated 60 Complete https://irct.ir/trial/84421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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). N/A Chemotherapy-induced nausea and vomiting. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Currently, no decision has been made in this regard by the team
public Mohammad Namazinia
Torbat Heydariyeh University of Medical Sciences, Mehr Boulevard, Valiasr Town
Torbat Heydariyeh Iran (Islamic Republic of) 9516160061 +98 51 5242 1000 mnamazi99@gmail.com Torbate-Heidaria University of Medical Sciences scientific Mahla Rajabzadeh
Nasibeh School of Nursing and Midwifery, Vesal Street, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 8916 rajabzadehm951@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female 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 R11 Nausea and vomiting Treatment - Other Placebo 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. 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. 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. Torbate-Heidaria University of Medical Sciences Approved 2025-05-18 Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences Torbat Heydariyeh University of Medical Sciences, Mehr Boulevard, Valiasr Town Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)