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IRCT20180603039968N1 IRCT 2018-10-10 Shiraz University of Medical Sciences The Effect of Patient Preparation by Multimedia Method on Anxiety, Pain, and Consumption of analgesic after Vitrectomy surgery. The Effect of Patient Preparation by Multimedia Method on Anxiety, Pain, and Consumption of analgesic after Vitrectomy surgery. 2018-07-23 anticipated 120 Complete https://irct.ir/trial/31745 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: block Each block represents a week. Each block size is equivalent to 4 days of a week when vitrectomy surgeries are conducted. The days when the vitrectomy surgery is conducted:Sunday, Monday, Tuesday and Thursday In this method, the study group is named as group A and the control group is named as group B. According to the existing conditions, 6 blocks are likely to be as follows: 1-AABB 2- ABAB 3 ABBA 4- BBAA 5- BAAB 6- BABA Selection of blocks is random and based on the cards' shuffling. By selecting each card, the samples are respectively placed in the control or study groups, Blinding description: • In order to blindness in the study, researchers and statistical advisers will be unaware of the allocation of patients in the control or intervention group. N/A Anxiety; Pain; Retinal detachment;vitrectomy؛ Preoperative preparation; Multimedia education. Intervention 1: Study group: After selecting the block, the allocation of patients to the study group is determined. On the night before the surgery, by considering the entry requirements of the study, and after having effective communication and gaining patient's trust, we will start to explain the process to the patient, gain his/her satisfaction and describe the research goals. Patient information is also recorded and the Spielberger questionnaire is filled in. Patients receive routine medical and nursing care according to the hospital policies. Afterward, some didactic photographs and videos will be shown to the patient by using a tablet, and his/her oral questions will be answered. The investigator explains to the patient about non-pharmacological pain control methods as the complementary of pharmacological therapies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured. Intervention 2: Control group: After selecting the block, the allocation of patients to the control group will be determined. On the night before the operation, by considering the entry requirements of the study, after describing the process and gaining satisfaction of the patient, the patient's information will be recorded and the Spielberger questionnaire will be filled in. the control group's patients will receive routine medical and nursing care according to hospital policies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured. Yes - There is a plan to make this available What will be shared: Mean of anxiety score, mean of pain anxiety score, mean of blood pressure, mean of consumption of analgesic When: 6 months after printing results To whom: All people Conditions: If allowed, Shiraz University of Medical Sciences and authors are allowed to access Where to obtain: esmaeil Kargar. Contact number: 00989380676316 esmaeil.kargarda@gmail.com Zahra molazem Associate Professor of Fatemeh Nursing and Midwifery Faculty molazemzah@yahoo.com How to obtain: Contact authors email Comments:
public Esmaeil Kargar
Shiraz - Khalili Street Khalili Hospital
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ +98 71 3629 1470 esmaeil.kargarda@gmail.com Shiraz University of Medical Sciences scientific Esmaeil Kargar
Shiraz - Khalili Street Khalili Hospital
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ +98 71 3629 1470 Esmaeil.kargarda@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) People's willingness to participate in the study Age range of 18 years old to 70 years old Hospitalization for at least 1 day before surgery No history of mental illness No prohibition of non-steroidal anti-inflammatory drugs and analgesics No addiction to drugs The patient should have the ability of seeing and hearing Patients who are candidates for single-eye vitrectomy surgery because of retinal detachment The patients will be placed in group I or group II according to the physical state of ASA 18 years 70 years Both Inability to speak Non-Iranian nationality Any factor that leads the patient to become unresponsive after surgery Having the history of attending anxiety control and problem-solving training classes N/A N/A Study group: After selecting the block, the allocation of patients to the study group is determined. On the night before the surgery, by considering the entry requirements of the study, and after having effective communication and gaining patient's trust, we will start to explain the process to the patient, gain his/her satisfaction and describe the research goals. Patient information is also recorded and the Spielberger questionnaire is filled in. Patients receive routine medical and nursing care according to the hospital policies. Afterward, some didactic photographs and videos will be shown to the patient by using a tablet, and his/her oral questions will be answered. The investigator explains to the patient about non-pharmacological pain control methods as the complementary of pharmacological therapies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured. Control group: After selecting the block, the allocation of patients to the control group will be determined. On the night before the operation, by considering the entry requirements of the study, after describing the process and gaining satisfaction of the patient, the patient's information will be recorded and the Spielberger questionnaire will be filled in. the control group's patients will receive routine medical and nursing care according to hospital policies. In the next step, 30 minutes before entering the operating room, patient's information is recorded and the Spielberger questionnaire is filled in. All patients undergo the general anesthesia. After surgery, at intervals before entering the department, and 1, 2, 3, and 4 hours after entering the department, the level of pain and consumption of pain killers will be measured. Anxiety. Timepoint: The night before the operation and 30 minutes before entering the operating room. Method of measurement: Spielberger questionnaire. Pain. Timepoint: In the recovery room before entering the department; 1,2,3,4 hours after entering the department. Method of measurement: VAS. Consumption of analgesics. Timepoint: In the recovery room before entering the department; 1,2,3,4 hours after entering the department. Method of measurement: mg. Shiraz University of Medical Sciences Approved 2018-06-02 Ethics Committee of Shiraz University of Medical Sciences Street Karim Khan Zand; Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)