About this trial
Intensive care units (ICUs) are specialized units where complex life-saving treatment and care activities are performed. Due to the treatment procedures performed in these specialized units, a large number of tools/equipment/devices/cables (endotracheal tubes, monitor cables, hemodialysis machines, mechanical ventilation, etc.) are placed on critically ill patients. These treatment devices restrict the movement of patients, creating obstacles to the independent performance of basic human needs such as personal hygiene. One of the individual hygiene practices frequently applied in ICUs is bed bathing. The application of bed bathing in ICUs varies according to institutional and clinical policies. In addition to its beneficial effects such as preventing infection, accelerating blood circulation, providing comfort and relaxation, etc., bed bathing also carries the risk of having a negative effect on physiological parameters. Eliminating or minimizing this risk is one of the primary care objectives of intensive care nurses. In this regard, it is crucial that bed baths, which are considered a routine nursing activity in ICUs, are performed in accordance with specific standards and protocols. In recent years, there has been an increase in the use of certain non-pharmacological care interventions in ICUs. One such intervention is auditory suggestion. Auditory suggestion refers to messages delivered through hearing to facilitate the adoption of specific thoughts, feelings, or behaviors. This method includes music, verbal suggestion, nature sounds, and other auditory stimuli that are believed to have the potential to influence the subconscious. In recent years, auditory suggestion has been integrated into the treatment processes of critically ill patients, particularly in intensive care units. This method is applied to reduce patients' stress, control pain, and support hemodynamic stability. Research has provided strong evidence supporting the physiological and psychological effects of auditory suggestion on both adult and pediatric patients. On the other hand, maintaining the patient's physiological parameters under control and increasing their comfort level while administering bed baths in the ICU are desired outcomes of nursing care. Based on this, the study was designed as a randomized controlled trial to investigate the effects of bed baths administered with auditory suggestion on physiological and comfort parameters in intensive care patients. The study, which will be conducted with a total of 66 ICU patients meeting the sample selection criteria, will apply the "bed bath protocol with auditory suggestion" to the study group and routine bed baths to the control group (only once). The study data will be collected using the "Patient Information Form" and the "Physiological and Comfort Parameters Monitoring Form" (data from the form will be collected and recorded before the bath, immediately after the bath, and 30 minutes after the bath). The study data will be analyzed using appropriate statistical methods.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years of age
Glasgow Coma Scale score: 8 and above
Richmond Agitation-Sedation Scale (RASS) score between +2 and -3
APACHE II score <10 points
Disqualifiers
Glasgow Coma Scale score: Under 8
Richmond Agitation-Sedation Scale (RASS) score of +3 and above, -4 and below
APACHE II score >10 points
Stayed in ICU for less than 24 hours
Trial design
Parallel
Treatments tested in this trial
Bed Bath With Auditory Hypnosis
Other interventionIn the bed bath protocol accompanied by audio suggestion, a 30-60 minute audio recording containing audio suggestions specific to the ICU patient will be prepared with the support of a specialist hypnotherapist. This audio recording will include the following messages: - The purpose of the bed bath, - Procedures to be performed during the bed bath, - The benefits of the bed bath, - Feeling safe during the bed bath, - Improvement in physiological parameters and comfort levels after the bed bath. While it is noted that auditory suggestion typically lasts 30-60 minutes, even a 15-minute auditory suggestion has been reported to provide benefits.
Treatment groups
Trial outcomes
Primary outcomes
Intensive Care Pain Observation Scale
It is a scale used specifically for the assessment of pain in unconscious patients receiving mechanical ventilation treatment in ICU. The scale consists of four parameters to assess facial expression, body movements, ventilator compliance and muscle tension. Each parameter is scored between 0 and 2. The minimum score is 0 and maximum score is 8. Scores between 0 and 4 show mild to moderate pain and scores between 5 and 8 show severe pain. Since pain is one of the most important markers of comfort, investigators planned to use this scale for criterion-related validity. It is expected that as pain increases, comfort level decreases.
Comfort Behaviors Checklist
The Comfort Behaviors Checklist consists of 30 behavioral indicators. In addition, Kolcaba suggests that if the list is the only measurement tool that measures comfort, the individual should give a numerical score to pain and comfort so that comfort can be objectively evaluated. Questions 2, 3, 5, 7, 8, 8, 9, 11, 12, 13, 19, 20, 21, 22, 24, 25, 27 are reverse coded. The list is scored on a 4-point Likert scale. When the list is completed, questions that are not applicable to the individual are given 0 points. The total number of questions answered is multiplied by 4 to obtain the possible score. The scores for all questions are calculated by reversing the questions, and the raw comfort score is obtained. Finally, the possible comfort scores are divided by the raw scores to obtain a decimal number. The decimal part of the obtained score is expressed as a two-digit number. The total score is calculated and then standardized to a scale of 0 (lowest comfort) to 120 (highest comfort).
Change in Heart Rate
Heart rate (beats per minute) will be measured before bed bath, immediately after, and 30 minutes after.
Change in Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure (mmHg) will be measured at three time points: before, immediately after, and 30 minutes after bed bath.
Sponsors and contacts
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Banu Terzi
Lead sponsor
Akdeniz University
Sponsor institution
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