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IRCT20190524043687N2 IRCT 2021-08-29 Arak University of Medical Sciences To investigate the effect of Solar plexus reflexology of sole of the foot on pain, anxiety and physiological Indicators caused by bone marrow aspiration (BMA) in patients with leukemia To investigate the effect of Solar plexus reflexology of sole of the foot on pain, anxiety and physiological Indicators caused by bone marrow aspiration (BMA) in patients with leukemia 2021-09-21 anticipated 70 Complete https://irct.ir/trial/57160 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling was done in an accessible (easy) method among all patients with leukemia (lymphoblastic or myeloblastic) who need bone marrow aspiration hospitalized in Ayatollah Khansari Hospital in Arak. Patients with equal number of members (1: 1) are randomly assigned to each of the intervention and control groups. Due to the gradual entry of samples into the research in this research, random allocation is done by a random sequence method by a table of random numbers in Excel software. To avoid the bias of random selection of individuals to study groups, it is hidden and this sequence remains hidden until the intervention. For this purpose, consecutive dark and numbered envelopes are used to enclose the sequences, Blinding description: The blind groups in this study include patients, an assistant research data collector, and a statistician; In such a way that none of the patients and also the data collector was aware of the allocation of patients to the two intervention and control groups and also the data obtained from this study without informing the statistical expert about the allocation of data to each intervention and control groups, Will be analyzed. (Explanation: In this study, the person collecting information is different from the person performing the intervention). N/A Condition 1: Acute lymphoblastic leukemia. Condition 2: Pain. Condition 3: Anxiety. Condition 4: Acute myeloblastic leukemia. Intervention 1: Intervention group: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 10 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the left foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. 5 minutes is for general massage of the sole of the foot and the next 10 minutes is for the relief of pain and anxiety caused by the procedure in the reflection points of the sole of the foot (points of the solar plexus, pituitary and spine). Then the same steps are performed on the patient's right foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague. Intervention 2: Control group: There is no special intervention in the control group and these patients receive only routine care. Yes - There is a plan to make this available What will be shared: Shared data include demographic information of participants' patients, type and method of intervention, information about anxiety, pain and physiological indicators of participants before and after the intervention. When: Start the access period 6 months after the results are published. To whom: Researchers and people working in nursing as well as people working in clinical nursing Conditions: The obtained data can be used for education, research and clinic of nursing. The applicant must be in the field of nursing. The data applicant should use the data only for education, research and clinic of nursing. Where to obtain: Ali Safdari, Department of critical care nursing, school of nursing, Arak university of medical sciences E mail:asafdari.nu@gmail.com How to obtain: After confirming that the data requester is in the field of nursing, the type of request will be answered immediately via email. Comments:
public Ali Safdari
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 asafdari.nu@gmail.com Arak University of Medical Sciences scientific Razieh Mokhtari
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 razieh.mokhtari91@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Catching leukemia (lymphoblastic or Myeloblastic) The age range of 18 to 60 Signature of informed consent form do bone marrow aspiration for the first time Have literacy to complete the questionnaire 18 years 60 years Both Previous experience or awareness of the impact of acupressure Lack of full consciousness, having mental, visual and auditory disorders History of taking anti-anxiety and sedative drugs one week before participating in the study (based on the contents of the file) Drug addiction Existence of an obstacle at the site of pressure (wounds, skin diseases, etc) Existence of sensory and motor disorders in the legs and minimal ability to walk on the legs (peripheral neuropathy or vascular problems in the lower extremities) C91.0 R52 F41.1 C92.0 Acute lymphoblastic leukemia [ALL] Pain, unspecified Generalized anxiety disorder Acute myeloblastic leukemia Treatment - Other Treatment - Other Intervention group: Performing massage intervention in the reflection points of the sole of the foot. For this purpose, the researcher will start the massage intervention 10 minutes after the patients enter the bed where they are hospitalized, after passing the reflexology training course and gaining the necessary skills. First, the researcher takes out his watch, ring, and jewelry and washes and warms his hands. Then, the researcher intervenes by being at the end of the patient's bed and observing a suitable position (to create better comfort, a small pillow is placed under the patient's knees).In the intervention group, to facilitate massage and better reflexology effect, 10 ml of pure olive oil with a temperature of 18-25 ° C is used. In the first step, lubricate the patient's foot for 1 minute and begin reflexology intervention. The massage of the left foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. 5 minutes is for general massage of the sole of the foot and the next 10 minutes is for the relief of pain and anxiety caused by the procedure in the reflection points of the sole of the foot (points of the solar plexus, pituitary and spine). Then the same steps are performed on the patient's right foot. In order to reduce the likelihood of distraction in patients, the intervention will be performed in a quiet and closed environment (if possible). It should be noted that massage intervention is performed for male patients by male researcher assistance and for female patients by a female colleague. Control group: There is no special intervention in the control group and these patients receive only routine care. Anxiety. Timepoint: Before intervention, immediately before intervention and after intervention. Method of measurement: The State-Trait Anxiety Inventory -Spielberger. Pain. Timepoint: Before intervention, immediately before intervention and after intervention. Method of measurement: Numeric pain rating scale (NRS). Heart beat. Timepoint: 5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention. Method of measurement: Number of beats per minute - pulse oximeter. Arterial blood oxygen saturation (SPO2). Timepoint: 5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention. Method of measurement: Percentage - pulse oximeter. Respiratory rate. Timepoint: 5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention. Method of measurement: Count per minute - count breathing by observation. Blood pressure. Timepoint: 5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention. Method of measurement: By sphygmomanometer. Arak University of Medical Sciences Approved 2021-08-24 Ethics committee of Arak University of Medical Sciences No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)