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IRCT20150919024080N22 IRCT 2022-11-27 Khoram-Abad University of Medical Sciences Effect of multicomponent intervention on delirium and sleep quality in orthopedic patients Effect of nurse-led multicomponent intervention on delirium, sleep quality and performance metrics in orthopedic surgery patients 2022-12-22 anticipated 96 Complete https://irct.ir/trial/66658 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the entry and exit criteria, samples from patients with orthopedic trauma requiring surgery referred to the male and female surgery departments of Imam Jafar Sadiq (AS) hospital in Aligudarz city are included in the study non-probably consecutively. In order to equalize the distribution of the two important confounders of age and sex, classes are created based on these two variables as "under 65 years/over 65 years" and "men's class/women's class" and then by block randomization in two The treatment and control groups are balanced. The size of each block is 4 items. The way to choose blocks randomly will be simple and with placement. STATA16 software will be used for block randomization, Blinding description: Coding of groups as group A (intervention) and group B (control) is done by a nurse who has no role in the study, and this coding remains with this independent nurse until the end of data analysis. The data analyst, the nurse assessor (data collector) and the study participants do not know about the random assignment of the groups. Blinding of the interventionist is not possible due to the nature of the study. N/A Orthopedic surgery patients. Intervention 1: Intervention group: First, in order to check the patient's medical history, allergy history, drug history and to ensure the absence of allergies and specific drug reactions, the electronic medical record of the patient is studied and he is also interviewed. In the intervention group, they will receive a 4-component intervention from 24 hours before to 48 hours after surgery - in the order explained below. In developing the schedule for the implementation of the intervention, it has been noted that the hours of implementation of the intervention components do not interfere with the hours of routine care in the ward and the distribution of meals to the patients. It should be noted that the resumption of interventions after the patient's surgery will be after the patient's clinical condition returns to a stable state. The entire intervention process will be carried out by the main researcher (student), and if there are two patients in the intervention group at the same time, the help of a trained and experienced researcher will be taken. Necessary arrangements will be made with the officials of the surgery departments to place the patients of the intervention group in a separate room. The four components of this intervention will start with the priority of patient pain management, and then continue with music therapy, cardio-respiratory support, and improving sleep hygiene for the intervention group. To control the pain, first, with the aim of checking the pain - after coordination with the patient's doctor - using the numerical pain rating scale (NRS) every 6 hours (6-12-18-24), the patient's pain score from one day before to two days It will be determined after surgery. Then, in order to treat the pain, analgesics will be prescribed by the nurse according to the developed protocol of literature review and expert panel. Medications mainly include nonsteroidal anti-inflammatory drugs such as ketorolac and paracetamol, and this protocol allows the nurse to independently administer analgesics to the patient. 30 to 60 minutes after the administration of the drugs, based on the method of administration and pain intensity, we will re-evaluate the patient's pain and if the pain is not controlled (i.e. pain score greater than 4) or there are side effects and adverse reactions to pain relievers, the appropriate decision will be made. Regarding the re-use of the analgesic or its discontinuation, it will be taken through consultation with the patient's physician. For patients with a known allergy to analgesics, the patient's physician will be consulted about an alternative medication. Oral analgesics will be prescribed with the expectation that the patient will not vomit and tolerate the oral route. For music therapy intervention, the type and style of music is based on the patient's preference and for 3 days (one day before and two days after the surgery), 2 times a day and each time for 30 minutes, between 15:00 and 21:00 based on The patient's preference for the patients of the intervention group will be implemented inside the department for the patient using the mp3 player and Sony brand headphones made in China. The volume of the music will be adjusted according to the patient's comfort and the intervention can be stopped at the request of the patient. Inspiratory muscle training will be done using the Threshold device (POWER breathe Classic, IMT Technologies Ltd, Birmingham, UK). Before starting the intervention, patients will be introduced to this device and will receive practical instructions on efficient diaphragmatic breathing. This intervention will be performed daily for 3 days and every day for 30 minutes from one day before to two days after surgery at 15:00. Each 30-minute session per day will consist of 3-minute training sets followed by short 1-minute rest intervals between sets, and will begin with the minimum pressure adjustable by the Threshold device and gradually increase and be performed in a comfortable position. The sleep hygiene intervention will also be carried out for 3 nights (one night before and two nights after the surgery) as follows: First, a sleep hygiene package to ensure the patient's comfort and convenience (taking into account the patient's preferences), including blindfolds, Earplugs, lavender-scented bags, and caffeine-free drinks to patients in the intervention group. Patients in the intervention group will be placed in a standard room (in terms of temperature and light, away from noise, TV, computer, etc.) Or wear glasses. Intervention 2: Control group: The control group will receive routine care including receiving narcotics if needed according to the physician's order, receiving haloperidol in hyperactive delirium attacks according to the physician's order and other prescribed treatment measures. 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 I have not decided yet and I do not have a plan
public Mansureh Sohrabi
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorramabad Iran (Islamic Republic of) 6814993165 +98 66 4333 4886 m.sohrabi.1317@gmail.com Khoram-Abad University of Medical Sciences scientific Mohammad Gholami
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
Khorammabad Iran (Islamic Republic of) 6814993165 +98 912 509 1279 gholami.m@lums.ac.ir Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Patients with orthopedic traumas including upper, lower limbs, pelvis and single fractures of the spine, who need at least 3 days of hospitalization after surgery in the surgery department and are on the surgery list Having consent to cooperate Not having a hearing problem (based on the whisper test) Age range of 55 years and above The duration of the patient's anesthesia for surgery is between 30 minutes and 3 hours Absence of confusion based on CAM test Mini–mental state examination (MMSE) score in the range of 18 to 30 Non-diagnosis of mental patients and history of taking haloperidol, risperidone, quetiapine, hypnotic herbal supplements and hypnotic drugs before hospitalization (self-report) 55 years no limit Both Transfer to another center and not providing treatment due to the death of the patient or medical reasons Concurrent participation in similar research Patients with dementia (MMSE less than 18) Patients with head, face, chest and spinal cord injuries Patients who undergo orthopedic surgery more than once during hospitalization Patients with history of traumatic brain injury, brain surgery and stroke in the last 6 months Occurrence of delirium or severe sleep disorder that makes the patient need drug treatment M84.9 Disorder of continuity of bone, unspecified Treatment - Other Treatment - Other Intervention group: First, in order to check the patient's medical history, allergy history, drug history and to ensure the absence of allergies and specific drug reactions, the electronic medical record of the patient is studied and he is also interviewed. In the intervention group, they will receive a 4-component intervention from 24 hours before to 48 hours after surgery - in the order explained below. In developing the schedule for the implementation of the intervention, it has been noted that the hours of implementation of the intervention components do not interfere with the hours of routine care in the ward and the distribution of meals to the patients. It should be noted that the resumption of interventions after the patient's surgery will be after the patient's clinical condition returns to a stable state. The entire intervention process will be carried out by the main researcher (student), and if there are two patients in the intervention group at the same time, the help of a trained and experienced researcher will be taken. Necessary arrangements will be made with the officials of the surgery departments to place the patients of the intervention group in a separate room. The four components of this intervention will start with the priority of patient pain management, and then continue with music therapy, cardio-respiratory support, and improving sleep hygiene for the intervention group. To control the pain, first, with the aim of checking the pain - after coordination with the patient's doctor - using the numerical pain rating scale (NRS) every 6 hours (6-12-18-24), the patient's pain score from one day before to two days It will be determined after surgery. Then, in order to treat the pain, analgesics will be prescribed by the nurse according to the developed protocol of literature review and expert panel. Medications mainly include nonsteroidal anti-inflammatory drugs such as ketorolac and paracetamol, and this protocol allows the nurse to independently administer analgesics to the patient. 30 to 60 minutes after the administration of the drugs, based on the method of administration and pain intensity, we will re-evaluate the patient's pain and if the pain is not controlled (i.e. pain score greater than 4) or there are side effects and adverse reactions to pain relievers, the appropriate decision will be made. Regarding the re-use of the analgesic or its discontinuation, it will be taken through consultation with the patient's physician. For patients with a known allergy to analgesics, the patient's physician will be consulted about an alternative medication. Oral analgesics will be prescribed with the expectation that the patient will not vomit and tolerate the oral route. For music therapy intervention, the type and style of music is based on the patient's preference and for 3 days (one day before and two days after the surgery), 2 times a day and each time for 30 minutes, between 15:00 and 21:00 based on The patient's preference for the patients of the intervention group will be implemented inside the department for the patient using the mp3 player and Sony brand headphones made in China. The volume of the music will be adjusted according to the patient's comfort and the intervention can be stopped at the request of the patient. Inspiratory muscle training will be done using the Threshold device (POWER breathe Classic, IMT Technologies Ltd, Birmingham, UK). Before starting the intervention, patients will be introduced to this device and will receive practical instructions on efficient diaphragmatic breathing. This intervention will be performed daily for 3 days and every day for 30 minutes from one day before to two days after surgery at 15:00. Each 30-minute session per day will consist of 3-minute training sets followed by short 1-minute rest intervals between sets, and will begin with the minimum pressure adjustable by the Threshold device and gradually increase and be performed in a comfortable position. The sleep hygiene intervention will also be carried out for 3 nights (one night before and two nights after the surgery) as follows: First, a sleep hygiene package to ensure the patient's comfort and convenience (taking into account the patient's preferences), including blindfolds, Earplugs, lavender-scented bags, and caffeine-free drinks to patients in the intervention group. Patients in the intervention group will be placed in a standard room (in terms of temperature and light, away from noise, TV, computer, etc.) Or wear glasses. Control group: The control group will receive routine care including receiving narcotics if needed according to the physician's order, receiving haloperidol in hyperactive delirium attacks according to the physician's order and other prescribed treatment measures. Delirium. Timepoint: Before the intervention and 48 and 72 hours after surgery. Method of measurement: Confusion Assessment Method (CAM). Sleep quality. Timepoint: Before the intervention and 48 hours after surgery. Method of measurement: Richards Campbell Sleep Questionnaire. Length of stay of orthopedic surgery patients after surgery in the surgery department. Timepoint: The length of the patient's stay in the ward after surgery until discharge. Method of measurement: Based on the patient's electronic file. Mortality rate during the first month after surgery. Timepoint: 30 days after surgery. Method of measurement: Telephone interview. Khoram-Abad University of Medical Sciences Approved 2022-10-19 Ethics committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Campus Kamalvavd, Vice Chancellor for Research and Technology Khorramabad Lorestan Iran (Islamic Republic of)