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IRCT20220209053981N1 IRCT 2022-02-24 Mashhad University of Medical Sciences The effect of multi-sensory stimuli on dependence on the elderly caregiver MSE The Effect Of multi-sensorial Environment (Snoezelen Therapy) On The Care Dependence Of The Elderly With Parkinson Disease. 2022-02-12 anticipated 70 Complete https://irct.ir/trial/61896 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is available. Members are then randomized based on blockchain. This method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that no significant imbalance is established between groups at any time during randomization, and at certain points the number of participants in each group is equal. For this method, the volume of each block must first be determined.(Example of a quadruple block). Then write a list of blocks and assign numbers to them ((1)AABB - (2)ABAB -(3)ABBA -(4)BBAA -(5) BABA -(6) BAAB ) Then select random numbers between one and 6 (Eg 1 4 5, etc.) and finally specify the treatment allocation list based on previous random numbers (AB AABB-BBAA-BABA-). The method of four random blocks (AABB, ABAB, BBAA, BABA,) which have been prepared using the Randomization site will be used to assign research units to two groups. The blocks will be prepared before sampling begins. Random sequences will be stored in closed-door envelopes until sampling, Blinding description: In this study, participants were randomly grouped and blinded. Participants become blind, so that people have no knowledge of the group to which they are assigned. N/A Parkinson's disease. Intervention 1: Intervention group: After determining the research units and preparing the snow room, the researcher will be fully acquainted with the snow room, the available equipment and how they work. After the researcher is fully acquainted with snozlen, the patients of the intervention group will be present in the hospital environment after coordination on the days of periodic visits or with the coordination and request of the patient. Patients then enter the room in groups of three. Preparations before starting Snoozelen: To reduce distraction and focus more, the cell phone should not be used in the room environment and we ask participants to turn off their cell phones and if they need a hygienic service or may be in If they need a session, be sure to go before starting the intervention.Before starting, we explain the snoozelen steps to the participants and answer any questions we may have, as well as reassuring them that they can leave the room whenever they want, thus showing them that they are completely on the environment. They have control. Now the intervention of snozlen begins. The olfactory stimulant of essential oil (5 drops of mint and one to two drops of water from Nicochemical Company) We spread the essential oil burning device in the environment and ask the participants to close their eyes and take four breaths 1-4-2 (2 seconds of inhalation). , 4 seconds of respiratory arrest, 1 second of exhalation) to reduce anxiety. Then we play the visual and auditory stimulus (a relaxing clip selected in consultation with a neurologist). During the broadcast, the researcher pays attention to each person's reaction and is recorded in the researcher's observation checklist (for example, the clip of the first session fascinated or disliked participant A). Thus, receiving 25 minutes of stimuli and the last 5 minutes of auditory and visual stimuli are turned off and the participant focuses again on the olfactory stimulus, and we ask the patient to breathe 1-4-2 again and to express his opinion and expectations. Tell the first session. Finally, we thank the participants and end the meeting. Each session provides them with different visual and auditory stimuli. After 8 sessions, the care dependency questionnaire is completed again. Intervention 2: Control group: Members of this group receive standard care only under the supervision of their physician and complete the care dependency questionnaire scale twice in 8 weeks. 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 Fatemeh Yousefli
Faculty of Nursing and Midwifery Mashhad, Ebn Sina St., Doctora Blvd.
Mashhad Iran (Islamic Republic of) 9197968280 +98 51 3859 1511 farnazyousefli98@gmail.com Mashhad University of Medical Sciences scientific Najmeh Valizade
Faculty of Nursing and Midwiffery, Ebn Sina Ave., Doctora Blvd.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 valizadehn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Elderly desire to participate in the study Elderly people over 60 with Parkinson's in the first and second stages Lack of cognitive problems with MMSE tools Absence of severe disturbances in the senses of smell, sight and hearing in the examination No active mental illness 60 years no limit Both Reluctance to participate in further study Participant's death Absence from 1 session out of 8 sessions of Snoezelen therapy Change the disease stage to end stage Incidence of cognitive impairment Activation of mental disorder G20 Parkinson's disease Rehabilitation Placebo Intervention group: After determining the research units and preparing the snow room, the researcher will be fully acquainted with the snow room, the available equipment and how they work. After the researcher is fully acquainted with snozlen, the patients of the intervention group will be present in the hospital environment after coordination on the days of periodic visits or with the coordination and request of the patient. Patients then enter the room in groups of three. Preparations before starting Snoozelen: To reduce distraction and focus more, the cell phone should not be used in the room environment and we ask participants to turn off their cell phones and if they need a hygienic service or may be in If they need a session, be sure to go before starting the intervention.Before starting, we explain the snoozelen steps to the participants and answer any questions we may have, as well as reassuring them that they can leave the room whenever they want, thus showing them that they are completely on the environment. They have control. Now the intervention of snozlen begins. The olfactory stimulant of essential oil (5 drops of mint and one to two drops of water from Nicochemical Company) We spread the essential oil burning device in the environment and ask the participants to close their eyes and take four breaths 1-4-2 (2 seconds of inhalation). , 4 seconds of respiratory arrest, 1 second of exhalation) to reduce anxiety. Then we play the visual and auditory stimulus (a relaxing clip selected in consultation with a neurologist). During the broadcast, the researcher pays attention to each person's reaction and is recorded in the researcher's observation checklist (for example, the clip of the first session fascinated or disliked participant A). Thus, receiving 25 minutes of stimuli and the last 5 minutes of auditory and visual stimuli are turned off and the participant focuses again on the olfactory stimulus, and we ask the patient to breathe 1-4-2 again and to express his opinion and expectations. Tell the first session. Finally, we thank the participants and end the meeting. Each session provides them with different visual and auditory stimuli. After 8 sessions, the care dependency questionnaire is completed again. Control group: Members of this group receive standard care only under the supervision of their physician and complete the care dependency questionnaire scale twice in 8 weeks. Care dependency score changes. Timepoint: At the beginning of the study before the intervention and after 8 sessions (8 weeks). Method of measurement: Care Dependence Questionnaire. Mashhad University of Medical Sciences Approved 2022-02-10 Ethical commitee of Mashhad University of medical science Faculty of Nursing and Midwifery Mashhad, Ebn Sina St., Doctora Blvd.. Mashhad Razavi Khorasan Iran (Islamic Republic of)