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IRCT20180107038251N6 IRCT 2022-03-04 Arak University of Medical Sciences Comparison of progressive muscle relaxation technique and inhalation aromatherapy with Lavender essence on anxiety and vital signs Comparison of progressive muscle relaxation technique and inhalation aromatherapy with Lavender essence on anxiety and vital signs in patients undergoing spinal anesthesia 2022-02-05 anticipated 120 Complete https://irct.ir/trial/61113 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be selected by convenient sampling methods and then randomly assigned to intervention with aroma A ,massage B, and control C groups by permutation blocks with six blocks ABCABC,AABBCC,AACCBB,CCABAB, Blinding description: Participants will be divided into three groups: intervention 1, intervention 2, and the control group. One group is called A and the other groups are called B and C. Before and after the intervention, information is collected by the outcome assessor who is unaware of the classification. Data analysis is also performed by a person who is unaware of groups. N/A Anxiety in patients undergoing Spinal anesthesia. Intervention 1: Intervention group: In progressive muscle relaxation technique group, 30 minutes before spinal anesthesia the patient's vital signs will be monitored and the demographic and Spielberger questionnaires will be filled in, then, patients will be asked to first contract the muscles of the feet to the muscles of the face and then relax. At the same time, patients will breathe deeply during relaxation. The selected position for gradual relaxation will be lying down. after surgery, the vital signs will be checked and the Spielberger question will be filled in. Intervention 2: Intervention group: 30 minutes before spinal anesthesia, the patient's vital signs will be monitored and recorded and the demographic questionnaire and Spielberger questionnaire will be filled in, then the pads saturated with 2 drops of 2% lavender essence, produced in Baricha Essence of Kashan Company, will be attached to the front of the chest. It will be inhaled for 20 minutes. Then, after surgery, the vital signs will be checked and the Spielberger question will be filled in. Intervention 3: Control group: Patients in the control group will receive routine care during this period and only research tools will be filled in by them. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Nazanin
سردشت، دانشگاه علوم پزشکی اراک، دانشکده پیراپزشکی
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3507 nazaninamini69@yahoo.com Arak University of Medical Sciences scientific Dr Hessamedin Modir
Arak University of Medical Sciences, Sardasht
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3507 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Alertness and ability to speak Patients aged over 18 years and under 65 years. Negative history of known mental illness Negative history of allergies or respiratory diseases Negative history of using anxiolytics, opioids, or strong analgesics Absence of severe pain due to underlying disease(cancer) No contraindications for frequent muscle contractions and expansions Ability to read, write and understand Persian 18 years 65 years Both Sudden pain not related to surgery Convulsion and any life-threatening emergencies History of mental illness being allergic to lavender inhalation Treatment with anti-depressants drugs Patients with cognitive, visual, or speech impairments Patients undergoing oncology surgery and major surgery Opioid, anti-anxiety drugs, muscle relaxants or any interfering drug requirement during spinal anesthesia Patients undergoing pilonidal sinus surgery or any surgery Which requires a prone position F41.9 Anxiety disorder, unspecified Prevention Prevention N/A Intervention group: In progressive muscle relaxation technique group, 30 minutes before spinal anesthesia the patient's vital signs will be monitored and the demographic and Spielberger questionnaires will be filled in, then, patients will be asked to first contract the muscles of the feet to the muscles of the face and then relax. At the same time, patients will breathe deeply during relaxation. The selected position for gradual relaxation will be lying down. after surgery, the vital signs will be checked and the Spielberger question will be filled in. Intervention group: 30 minutes before spinal anesthesia, the patient's vital signs will be monitored and recorded and the demographic questionnaire and Spielberger questionnaire will be filled in, then the pads saturated with 2 drops of 2% lavender essence, produced in Baricha Essence of Kashan Company, will be attached to the front of the chest. It will be inhaled for 20 minutes. Then, after surgery, the vital signs will be checked and the Spielberger question will be filled in. Control group: Patients in the control group will receive routine care during this period and only research tools will be filled in by them. Anxiety. Timepoint: 30 minutes before spinal anesthesia and after surgery. Method of measurement: Spielberger Standard Questionnaire. Respiratory rate. Timepoint: 30 minutes before spinal anesthesia and after surgery. Method of measurement: Chest observation. Pulse rate. Timepoint: 30 minutes before spinal anesthesia and after surgery. Method of measurement: Pulse oximetry. Temperature. Timepoint: 30 minutes before spinal anesthesia and after surgery. Method of measurement: Thermometer. Blood pressure. Timepoint: 30 minutes before spinal anesthesia and after surgery. Method of measurement: Blood pressure monitor. Satisfaction level. Timepoint: From the beginning of anesthesia to the end of surgery. Method of measurement: 5-point Likert scale 5-point Likert scale. Arak University of Medical Sciences Approved 2021-12-05 Arak University of Medical Sciences Arak University of Medical Sciences, Railroad Street, Alamol Huda Street Arak Markazi Iran (Islamic Republic of)