The Effect of Auditory Stimulation and the "Love Glove" Technique
The Effect of Auditory Stimulation and the "Love Glove" Technique on Vital Signs in Unconscious Patients
The aim of this study was to determine the effect of the "love glove" intervention, combined with the voices of family members and nurses, on vital signs in unconscious patients in the intensive care unit. The following items will be used to collect research data: Patient Information Form (Appendix I), Data Recording Form (Appendix II), MP3 player, external headphones and voice recorder, latex gloves, and thermometer.
Data Collection Tools:
Patient Identification Form : A form containing patients' sociodemographic characteristics and their Glasgow Coma Scale score prior to the start of the study Data Recording Form: A form used to record patients' level of consciousness and hemodynamic parameters before and after the auditory stimulation procedure.
Methods This study is a randomized controlled trial designed to determine the effect of applying a family member's voice, a nurse's voice, and the "love glove" on vital signs in unconscious patients admitted to the intensive care unit. Following approval from the ethics committee, the study is planned to be conducted with comatose patients admitted to the hospital's intensive care unit.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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MANİSAYunusemre
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Manisa、MANİSAYunusemre、土耳其（türkiye）
- Kivan Çevik Kaya
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients in a coma who have been hospitalized in the intensive care unit for at least 48 hours, have a Glasgow Coma Scale score of 8 or lower,
- have no hearing problems,
- are hemodynamically stable,
- are either on mechanical ventilation or breathing spontaneously, have no history of head trauma,
- have received informed consent from their legal representative
Exclusion Criteria:
- Patients with open wounds,
- those diagnosed with brain death,
- those whose sedative or analgesic doses were adjusted during the study,
- those with severe hemodynamic instability,
- patients with latex allergies
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制
无干预
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实验性的：family member's voice
A pre-recorded message will be played and recorded for the patient's family members, featuring a prepared script that includes the patient's name, the family member's name, and their relationship to the patient, as well as information on the patient's location and phrases conveying hope and love.
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The audio recording of the patient's family member will be made in a quiet and calm room.
Care will be taken to select family members who have a strong emotional bond with the patient for the recording.
When determining which family member will be recorded, the patient's first-degree relatives will be consulted, and the family's collective decision will be taken into account; in addition to the family member being recorded, consent will be obtained from another family member who volunteers to serve as a witness for this person via a consent form.
A preliminary interview will be conducted with the family member selected for the audio recording in a suitable room, and they will be asked to recite the standard script.
Family members will be given as much time as they need to prepare for the audio recording.
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实验性的：nurse's voice
The audio recording made by the researcher will also be played for the other intervention group, to whom the nurse's voice will be played
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The audio recording containing the standard script to be read by the researcher will also be made in a quiet, calm room
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实验性的：Love glove
The group receiving the "love glove" treatment will be given a treatment involving latex gloves filled with warm water and air
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Latex medical gloves will be filled with warm water (37°C) and air to prevent pressure ulcers and provide a sensation of human touch.
The gloves will be connected to each other and placed on both of the patient's hands, and the treatment will be applied for 15 minutes.
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实验性的：family member's voice+glove of love
The patient's family members voice and the "glove of love" will be used together
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where the patient's voice and the "glove of love" are used together
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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blood pressure
大体时间：Twice a day for 7 days
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Blood pressure were recorded on the Form before and after the blood sampling procedure.
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Twice a day for 7 days
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pulse
大体时间：Twice a day for 7 days
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Pulse were recorded on the Form before and after the blood sampling procedure.
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Twice a day for 7 days
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oxygen saturation
大体时间：Twice a day for 7 days
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oxygen saturation were recorded on the Form before and after the blood sampling procedure.
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Twice a day for 7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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