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IRCT20190524043687N3 IRCT 2021-12-24 Arak University of Medical Sciences Comparison of the effect of solar plexus point reflexology of plantar and palmar on anxiety and physiological parameters of patients undergoing colonoscopy Comparison of the effect of solar plexus point reflexology of plantar and palmar on anxiety and physiological parameters of patients undergoing colonoscopy 2022-01-08 anticipated 105 Complete https://irct.ir/trial/58750 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples are selected in an available sampling way from all colonoscopy candidate patients admitted to Amir Al-Momenin Hospital in Arak. Then patients with an equal number of members are randomly assigned to each of the intervention and control groups. The block randomization method will be used. To avoid the bias of random selection of individuals to study, groups are 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, data collectors, and a statistician; in such a way that none of the data collectors were 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. N/A Condition 1: Abnormal findings on diagnostic imaging and in function studies, without diagnosis. Condition 2: Anxiety. Intervention 1: Intervention group1: 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, 3 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 right foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are performed on the patient's left 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: Intervention group2: In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, so that the researcher first lubricates the patient's right hand for 1 minute and begin reflexology intervention. The massage of the right hand at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are done for the left hand. Intervention 3: 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) Colonoscopy candidate Age range 18 to 65 years Signing an informed consent form Colonoscopy candidate for the first time Have a minimum reading and writing literacy to complete the questionnaire 18 years 65 years Both Having emergency colonoscopy order Have previous experience or knowledge of the effects of acupressure Lack of full consciousness, having mental, visual and auditory disorders 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) R93.8 F41.1 Abnormal findings on diagnostic imaging of other specified body structures Generalized anxiety disorder Treatment - Other Treatment - Other Other Intervention group1: 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, 3 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 right foot at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are performed on the patient's left 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 group2: In intervention group 2, the researcher performs the above steps on the patient's hand as in intervention group 1, so that the researcher first lubricates the patient's right hand for 1 minute and begin reflexology intervention. The massage of the right hand at a slow pace, with a regular rhythm and with a depth that is tolerable by the patient lasts for 15 minutes. Reflex points include the head, pituitary gland, diaphragm, lungs, solar plexus, and adrenal gland. Then the same steps are done for the left hand 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. Heart beat. Timepoint: Before the intervention, immediately before the intervention, after the intervention. Method of measurement: Number of beats per minute - pulse oximeter. Arterial blood oxygen saturation (SPO2). Timepoint: Before the intervention, immediately before the intervention, after the intervention. Method of measurement: Percentage - pulse oximeter. Respiratory rate. Timepoint: Before the intervention, immediately before the intervention, after the intervention. Method of measurement: Count per minute - count breathing by observation. Blood pressure. Timepoint: Before the intervention, immediately before the intervention, after the intervention. Method of measurement: By sphygmomanometer. Arak University of Medical Sciences Approved 2021-11-14 Ethics Committee of the Arak University of Medical Sciences Sardasht St., Basij Square, Ethics Committee of Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)