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IRCT20230428058019N1 IRCT 2023-05-25 Tabriz University of Medical Sciences The effect of massage with clove oil on pain and anxiety caused by IT/LP The effect of effleurage massage with clove oil on IT/LP pain and anxiety among children with cancer: A randomized clinical trial. 2023-05-07 anticipated 39 Complete https://irct.ir/trial/69994 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation of participants to each of the study groups and the order of their placement in the groups will be done using the table of random numbers created with the Random Sample Numbers software by the respected Professor of Statistics. The participants will be selected using the available sampling method and will be divided into each group (intervention 1 and 2 and control (without intervention)) by random allocation using the random block method with the software. RAS will be generated, Blinding description: Due to the aromatic nature of clove oil and the ability to differentiate between clove oil and sweet almond oil through smell, blinding is not possible for the researcher and participants, and blinding in this study is only done for the analyst (statistical consultant). will be done, in such a way that they will only know the studied groups in the form of a and b and they will not know which participant will receive which intervention. 3 cancer. Intervention 1: Intervention group: Intervention group: 1 Working method in intervention group 1 (Effleurage massage group with clove oil) In addition to receiving routine care, this group received effleurage massage with clove oil, which has an analgesic effect to relieve the pain caused by IT/LP. Effleurage massage was performed 15 minutes before IT/LP for 5 minutes. 20 minutes before the child was taken to the procedure room for IT/LP and before the massage therapy, how to use the VAS pain and CAM anxiety measurement tool was explained to the child, and the child's pain and anxiety scores were evaluated based on the tools mentioned was measured. After completing the three-part tool including demographic questionnaire, VAS pain measurement tool and CAM anxiety measurement tool, the patient's basic pain and anxiety before IT/LP procedure and massage intervention were measured and determined. Then, respecting his privacy, the child was placed in a comfortable position on the bed in his room. The waist area was uncovered. Before starting the massage, the hands were warmed and slippery with oil and placed on the skin of the desired area. Then two-handed efflorescence massage was applied using palms and fingers in circular and linear motions in the direction of blood flow from the bottom to the heart and applying low pressure with surface rubbing for 5 minutes depending on the child's tolerance. For massage, clove oil from Shefai Kurdistan Company was used in the amount of 3-4 cc per massage (one third of the dose used in adults for pain relief according to the study of Rahmayanti45). After the massage, 15 minutes were given for the local absorption of the oil and the child was placed in a comfortable position on his bed. After 15 minutes of the massage, the child was taken to the procedure room and the IT/LP procedure was performed on him by the doctor. 3 minutes after the completion of IT/LP, according to the general state of the child and before the child leaves the procedure room, the pain score experienced by the child during IT/LP using the VAS tool and the anxiety score experienced during the IT/LP procedure LP was evaluated and determined using the CAM tool. Intervention 2: Intervention group: In intervention group 2 (Effleurage massage with sweet almond oil), this group also received exfoliation massage with sweet almond oil in addition to receiving routine care. Massage was done 15 minutes before IT/LP for 5 minutes. According to the study of Batalha40, sweet almond oil, which does not have many analgesic properties, was used as a placebo in intervention group 2. In this study, sweet almond oil was used by Barij Essans Pharmaceutical Company. Effleurage massage was performed 15 minutes before IT/LP for 5 minutes. 20 minutes before the child was taken to the procedure room for IT/LP and before the massage therapy, how to use the VAS pain and CAM anxiety measurement tool was explained to the child, and the child's pain and anxiety scores were evaluated based on the tools mentioned was measured. After completing the three-part tool including demographic questionnaire, VAS pain measurement tool and CAM anxiety measurement tool, the patient's basic pain and anxiety before IT/LP procedure and massage intervention were measured and determined. Then, respecting his privacy, the child was placed in a comfortable position on the bed in his room. The waist area was uncovered. Before starting the massage, the hands were warmed and slippery with oil and placed on the skin of the desired area. Then two-handed efflorescence massage was applied using palms and fingers in circular and linear motions in the direction of blood flow from the bottom to the heart and applying low pressure with surface rubbing for 5 minutes depending on the child's tolerance. For massage, 3-4 cc of sweet almond oil was used for each massage (one third of the dose used in adults for pain relief according to the study of Rahmayanti45). After the massage, 15 minutes were given for the local absorption of the oil and the child was placed in a comfortable position on his bed. After 15 minutes of the massage, the child was taken to the procedure room and the IT/LP procedure was performed on him by the doctor. 3 minutes after the completion of IT/LP, according to the general state of the child and before the child leaves the procedure room, the pain score experienced by the child during IT/LP using the VAS tool and the anxiety score experienced during the IT/LP procedure LP was evaluated and determined using the CAM tool. Intervention 3: Control group: Working method in the control group (without intervention), this group only received routine care before, during and after the IT/LP procedure, and no intervention was done by the researcher, and only the assessment of pain and anxiety before and after the procedure with tools It was mentioned and it was done and recorded in the mentioned times like the groups of intervention. Yes - There is a plan to make this available What will be shared: Demographic characteristics of subjects and pain and anxiety scores during the intervention When: "Starting the access period 6 months after printing the results" To whom: Researchers working in academia and industry Conditions: It is possible to use the data with the permission of the researcher and citing the study. Where to obtain: The full name of the responsible person Leila Valizadeh email fatemehrahimi028@gmail.com job position Professor Street Address Tabriz / Southern Shariati Street / College of Nursing and Midwifery City Tabriz State East Azarbaijan Country Islamic Republic of Iran Postal code 5178763914 Phone +98 41 3477 0649 Cellular phone +98 921 715 5629 How to obtain: It takes about a month to send an email to the responsible person and review the request by him.(masculine) Comments:
public Leila Valizadeh
Tabriz / Southern Shariati Street / College of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5178763914 +98 41 3477 0649 fatemehrahimi028@gmail.com Tabriz University of Medical Sciences scientific Leila Valizadeh
Tabriz / Southern Shariati Street / College of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5178763914 +98 41 3477 0649 fatemehrahimi028@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of cancer and hospitalization in the ward . Prescribing LP and receiving IT Children aged 7 to 11 years 7 years 11 years Both 1. The order to receive midazolam or other sedatives before the procedure 2. The child's restlessness and intolerance of research conditions 3. Loss of consciousness and lack of awareness of time, place and person 4. Severely ill and end-stage child 5. The need to observe contact precautions 6. Fever, risk of bleeding (platelet count less than 20,000), leukopenia 7. Inability to communicate verbally (deafness) and vision disorders and physical defects, Down's syndrome and genetic diseases that disrupt the expression and experience of pain. Having a wound, fracture, infection, redness and abnormal swelling in the massage area 8. People undergoing IT/LP for the first time. History of allergy to clove and sweet almond oil C90 Multiple myeloma and malignant plasma cell neoplasms Treatment - Drugs Placebo N/A Intervention group: Intervention group: 1 Working method in intervention group 1 (Effleurage massage group with clove oil) In addition to receiving routine care, this group received effleurage massage with clove oil, which has an analgesic effect to relieve the pain caused by IT/LP. Effleurage massage was performed 15 minutes before IT/LP for 5 minutes. 20 minutes before the child was taken to the procedure room for IT/LP and before the massage therapy, how to use the VAS pain and CAM anxiety measurement tool was explained to the child, and the child's pain and anxiety scores were evaluated based on the tools mentioned was measured. After completing the three-part tool including demographic questionnaire, VAS pain measurement tool and CAM anxiety measurement tool, the patient's basic pain and anxiety before IT/LP procedure and massage intervention were measured and determined. Then, respecting his privacy, the child was placed in a comfortable position on the bed in his room. The waist area was uncovered. Before starting the massage, the hands were warmed and slippery with oil and placed on the skin of the desired area. Then two-handed efflorescence massage was applied using palms and fingers in circular and linear motions in the direction of blood flow from the bottom to the heart and applying low pressure with surface rubbing for 5 minutes depending on the child's tolerance. For massage, clove oil from Shefai Kurdistan Company was used in the amount of 3-4 cc per massage (one third of the dose used in adults for pain relief according to the study of Rahmayanti45). After the massage, 15 minutes were given for the local absorption of the oil and the child was placed in a comfortable position on his bed. After 15 minutes of the massage, the child was taken to the procedure room and the IT/LP procedure was performed on him by the doctor. 3 minutes after the completion of IT/LP, according to the general state of the child and before the child leaves the procedure room, the pain score experienced by the child during IT/LP using the VAS tool and the anxiety score experienced during the IT/LP procedure LP was evaluated and determined using the CAM tool. Intervention group: In intervention group 2 (Effleurage massage with sweet almond oil), this group also received exfoliation massage with sweet almond oil in addition to receiving routine care. Massage was done 15 minutes before IT/LP for 5 minutes. According to the study of Batalha40, sweet almond oil, which does not have many analgesic properties, was used as a placebo in intervention group 2. In this study, sweet almond oil was used by Barij Essans Pharmaceutical Company. Effleurage massage was performed 15 minutes before IT/LP for 5 minutes. 20 minutes before the child was taken to the procedure room for IT/LP and before the massage therapy, how to use the VAS pain and CAM anxiety measurement tool was explained to the child, and the child's pain and anxiety scores were evaluated based on the tools mentioned was measured. After completing the three-part tool including demographic questionnaire, VAS pain measurement tool and CAM anxiety measurement tool, the patient's basic pain and anxiety before IT/LP procedure and massage intervention were measured and determined. Then, respecting his privacy, the child was placed in a comfortable position on the bed in his room. The waist area was uncovered. Before starting the massage, the hands were warmed and slippery with oil and placed on the skin of the desired area. Then two-handed efflorescence massage was applied using palms and fingers in circular and linear motions in the direction of blood flow from the bottom to the heart and applying low pressure with surface rubbing for 5 minutes depending on the child's tolerance. For massage, 3-4 cc of sweet almond oil was used for each massage (one third of the dose used in adults for pain relief according to the study of Rahmayanti45). After the massage, 15 minutes were given for the local absorption of the oil and the child was placed in a comfortable position on his bed. After 15 minutes of the massage, the child was taken to the procedure room and the IT/LP procedure was performed on him by the doctor. 3 minutes after the completion of IT/LP, according to the general state of the child and before the child leaves the procedure room, the pain score experienced by the child during IT/LP using the VAS tool and the anxiety score experienced during the IT/LP procedure LP was evaluated and determined using the CAM tool. Control group: Working method in the control group (without intervention), this group only received routine care before, during and after the IT/LP procedure, and no intervention was done by the researcher, and only the assessment of pain and anxiety before and after the procedure with tools It was mentioned and it was done and recorded in the mentioned times like the groups of intervention. Pain. Timepoint: The pain variable will be evaluated 20 minutes before the intervention and 3 minutes after the intervention. Method of measurement: visual analog scale of pain. Anxiety. Timepoint: The anxiety variable will be evaluated 20 minutes before the intervention and 3 minutes after the intervention. Method of measurement: Children’s Anxiety Meter-Scale. Tabriz University of Medical Sciences Approved 2022-01-11 Research Ethics Committee of Tabriz University of Medical Sciences Resalat, No. 66, Koche Eskoi, Sosangerd Street Tabriz East Azarbaijan Iran (Islamic Republic of)