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IRCT20241101063561N1 IRCT 2024-11-21 Shiraz University of Medical Sciences Effect of foot reflex massage in leukemia patients The effect of foot reflexology massage on pain, anxiety and sleep quality after bone marrow sampling in leukemia patients 2024-11-20 anticipated 62 Complete https://irct.ir/trial/80097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: By using the random allocation method with the replacement block method, people are divided into two control and intervention groups. For this purpose, using random block generation software on the Internet, 19 random blocks of 4 are formed. The content of each block is placed in a sealed envelope. After choosing the desired person, the envelopes are opened in order and based on the envelope, they are assigned to one of the intervention and control groups, Blinding description: In this study, the person doing the data collection and the person doing the analyzes were blinded to the groups until the end of the work. N/A Bone marrow sampling in patients with leukemia. Intervention 1: Intervention group: The patient will lie down on the bed in a quiet place. The researcher will perform reflexology for twenty minutes. The reflexology method includes preparation, heating and stimulation and massage techniques. First, the researcher rubs his hands together to warm both hands, and secondly, he warms the patient's feet by rubbing them with sweet almond oil. turning outwards and inwards and movements in the heels. When the foot is warmed up enough, the massage will be done using the fingers and applying pressure of about 0.5 cm. The researcher applies pressure on the thumb and solar plexus, the inner and outer edge of the foot, the inner edge of the sole of the foot, and the wrist, which are related to the quality of sleep, fatigue, back pain, shoulder pain, hands and feet, respectively. In reflexology, the big toe, medial edge, top and base of the big toe will be stimulated. The inner edge of the leg corresponding to the cervical spine, chest, lumbar spine and sacrum will also be stimulated. Reflex points on the outer edge of the leg, such as the feet, knees, lower back, elbows, arms and shoulders, will also be stimulated. Reflexology will also be done on the inner edge of the foot, the sole of the foot, and the heel of the ankle, which will stimulate the sciatic nerve and the lower back. Reflexology may have side effects such as leg swelling, frequent urination, defecation and fatigue. Foot reflex massage intervention will be performed by the researcher in six sessions and for twenty minutes for each leg in three days and twice a day. Data collection is related to pain intensity before the intervention and in the evening of the first, second and third days after the intervention at 9:00 and 17:00. The patient's anxiety before the intervention and in the evening of the first, second and third days after the intervention is at 9:00 and 17:00 and the quality of sleep is at 9:00 a.m. before the intervention and in the morning of the first, second and third day after the intervention. They will be recorded by the researcher or research assistant. Intervention 2: Control group: In the control group, they will only receive massage with almond oil to warm their feet and the main massage stage will not be performed for them, and the level of pain before the intervention and twice daily in the morning and evening, the level of anxiety before the intervention and twice daily in the morning And the evening and the amount of sleep quality of the patients will be measured and recorded before the intervention and every morning. Yes - There is a plan to make this available What will be shared: After the end of the study, it is possible to share the data When: After the end of the study, it is possible to share data for one year To whom: Researchers working in academic and scientific institutions of medical sciences Conditions: Analysis on documents and data is allowed Where to obtain: Mrs. Dr. Khatereh Rostami is responsible for this project. Phone Number: +98 71 3647 4254 Address: Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province Email: khatereh.rostami.nursing@gmail.com How to obtain: In order to access the information of the study, first of all, contact should be made with the manager of this project, Dr. Khatereh Rostami, whose profile is attached below, and then after reviewing the relevant request and meeting the requirements, the documents will be sent as soon as possible. Phone: +98 71 3647 4254 Address: Fars Province, Shiraz, Namazi Square, the entrance of Namazi Hospital, Hazrat Fatima College of Nursing and Midwifery Email: khatereh.rostami.nursing@gmail.com Comments:
public Khatereh Rostami
Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province
SHIRAZ Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 khatereh.rostami.nursing@gmail.com Shiraz University of Medical Sciences scientific Khatereh Rostami
Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province
SHIRAZ Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 khatereh.rostami.nursing@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The age of the patients should be between 18 and 60 years 2. The patient's candidacy for bone marrow sampling according to the doctor's diagnosis 3. The ability to tolerate the sole reflex massage technique 4. Not having a history of known mental illness that is treated with anti-anxiety and sedative drugs before the intervention. 5. Patients' satisfaction with participating in the research project 18 years 60 years Both Reluctance to stay in the study 2. Occurrence of sudden complications after bone marrow sampling, such as shock, severe bleeding. C95 Leukemia of unspecified cell type Other Other Intervention group: The patient will lie down on the bed in a quiet place. The researcher will perform reflexology for twenty minutes. The reflexology method includes preparation, heating and stimulation and massage techniques. First, the researcher rubs his hands together to warm both hands, and secondly, he warms the patient's feet by rubbing them with sweet almond oil. turning outwards and inwards and movements in the heels. When the foot is warmed up enough, the massage will be done using the fingers and applying pressure of about 0.5 cm. The researcher applies pressure on the thumb and solar plexus, the inner and outer edge of the foot, the inner edge of the sole of the foot, and the wrist, which are related to the quality of sleep, fatigue, back pain, shoulder pain, hands and feet, respectively. In reflexology, the big toe, medial edge, top and base of the big toe will be stimulated. The inner edge of the leg corresponding to the cervical spine, chest, lumbar spine and sacrum will also be stimulated. Reflex points on the outer edge of the leg, such as the feet, knees, lower back, elbows, arms and shoulders, will also be stimulated. Reflexology will also be done on the inner edge of the foot, the sole of the foot, and the heel of the ankle, which will stimulate the sciatic nerve and the lower back. Reflexology may have side effects such as leg swelling, frequent urination, defecation and fatigue. Foot reflex massage intervention will be performed by the researcher in six sessions and for twenty minutes for each leg in three days and twice a day. Data collection is related to pain intensity before the intervention and in the evening of the first, second and third days after the intervention at 9:00 and 17:00. The patient's anxiety before the intervention and in the evening of the first, second and third days after the intervention is at 9:00 and 17:00 and the quality of sleep is at 9:00 a.m. before the intervention and in the morning of the first, second and third day after the intervention. They will be recorded by the researcher or research assistant Control group: In the control group, they will only receive massage with almond oil to warm their feet and the main massage stage will not be performed for them, and the level of pain before the intervention and twice daily in the morning and evening, the level of anxiety before the intervention and twice daily in the morning And the evening and the amount of sleep quality of the patients will be measured and recorded before the intervention and every morning PAIN. Timepoint: The time of data collection is related to pain intensity before the intervention and in the evening of the first, second and third days after the intervention at 9:00 and 17:00. Method of measurement: PAIN VISUAL SCALE. ANXIETY. Timepoint: The time of data collection is related to pain intensity before the intervention and in the evening of the first, second and third days after the intervention at 9:00 and 17:00. Method of measurement: Spielberger Situational Anxiety Questionnaire. Sleep quality. Timepoint: Sleep quality before the intervention and in the morning of the first, second and third day after the intervention at 9 am and their information will be recorded by the researcher or assistant researcher. Method of measurement: Petersburg Sleep Quality Questionnaire. Shiraz University of Medical Sciences Approved 2024-10-05 Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s Hazrat Fatemeh College of Nursing and Midwifery, Entrance to Namazi Hospital, Namazi Square, Shiraz, Fars Province shiraz Fars Iran (Islamic Republic of)