Clinical trial NCT07019467: Bed Bath With Auditory Hypnosis on ICU Patients
Official title: The Effect of Bed Bath Given to Intensive Care Unit Patients With Auditory Hypnosis on Physiological and Comfort Parameters: a Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Care
Keywords: auditory hypnosis
bed bath
comfort
critical ill patients
ICU
physiological parameters
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, randomised controlled, single-blind study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Intensive care units (ICU) are specialized units where complex life-saving treatment and care activities are performed. Due to the treatment interventions applied in these special units, a large number of tools/equipment/devices/cables (intubation tube, monitor cables, hemodialysis device, mechanical ventilation, etc.) are placed in critically ill patients. These treatment equipments restrict the movement of patients and hinder the independent fulfillment of the most basic human needs such as personal hygiene. One of the most common individual hygiene practices in ICUs is bed bathing. At the same time, in addition to the beneficial effects of bed bathing such as preventing infection, accelerating blood circulation, providing comfort and relaxation, etc., there is also a risk of negative effects on physiological parameters. Elimination or minimization of this risk is one of the primary care-giving goals of the intensive care nurse.

Considering the duties, authorities and responsibilities of intensive care nurses, ensuring the safety and comfort of the critical patient in the ICU should be the primary goal of the nurse. In this direction, some non-pharmacological applications can be utilized to prevent the risk of deterioration in the patient's physiological parameters and to increase his/her comfort during bed bathing, which is frequently applied to critically ill patients in the ICU and seen as an ordinary procedure.

One of these applications, the effects of which have been investigated on critically ill patients in ICU in recent years, is auditory suggestion. Auditory suggestion refers to verbal or auditory messages given through hearing to facilitate individuals to adopt certain thoughts, feelings or behaviors. This method includes music, verbal suggestion, nature sounds and other auditory stimuli that are thought to have the potential to influence the subconscious mind.

Recent studies have shown that auditory suggestion can play an important role in improving the physiological and psychological parameters of critically ill patients, especially in intensive care units (ICU). Clinical applications of auditory suggestion often include music therapy, white noise, nature sounds, meditation music and audio recordings with subliminal messages. Music therapy is the most common and most researched form of auditory suggestion. In the mid-20th century, music therapy began to be used as an adjunct therapy in the treatment of various psychological and neurological disorders. However, in modern medicine and psychology, the physiological effects of auditory suggestion are being taken more into account. Studies on the use of auditory suggestion, especially in intensive care units, show that this method can increase the hemodynamic stability of patients and reduce their stress levels.

With the sense of hearing, which is the last lost sense of hearing of human beings, the physiological and comfort parameters of the patients can be positively changed by the bed bath given to critically ill patients accompanied by auditory suggestion. Since patients who cannot communicate verbally have no control over themselves and their environment, it is known that talking with these patients has a therapeutic value. Accordingly, the aim of this study was to examine the effect of bed bath given to intensive care unit patients accompanied by auditory suggestion on physiologic and comfort parameters.

Eligibility criteria: Inclusion Criteria:

* 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
* Stayed in the ICU for at least 24 hours
* Continues breathing with invasive mechanical ventilation support device
* Not receiving antihypertensive treatment
* Not taking inotropic drugs that directly affect vital signs (esmolol, noradrenaline, dopamine, adrenaline, dopamine, nitrate, etc.)
* No wounds/injuries that would prevent bed bathing
* There is no harm in moving it
* Routine blood gas values (no extra blood gas sample will be taken for this study)

Exclusion Criteria:

* 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
* Referred to another ICU or clinic during the collection of research data
* Intubated in less than 24 hours
* Treatment protocol changed (hypertension and inotrope etc. drugs started)
* Disturbed physiological parameters during bed bathing
* Restricted mobility
* No request for blood gas collection/no blood gas value
* Patients who exit during the study period will be excluded from the study.

Primary outcomes:
measure: Intensive Care Pain Observation Scale
timeFrame: Before bed bath, immediately and 30 minutes after the bed bat
measure: Comfort Behaviors Checklist
timeFrame: Before bed bath, immediately and 30 minutes after the bed bath
measure: Change in Heart Rate
timeFrame: Baseline (pre-bed bath), immediately post-bed bath, and 30 minutes post-bed bath
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, immediately post, and 30 minutes post-intervention
measure: Change in Respiratory Rate
timeFrame: Baseline, immediately post, 30 minutes post
measure: Change in Body Temperature
timeFrame: Baseline, immediately post, 30 minutes post
measure: Change in Peripheral Oxygen Saturation (SpO₂)
timeFrame: Baseline, immediately post, 30 minutes post
measure: Change in Blood pH
timeFrame: Baseline, immediately post, 30 minutes post
measure: Change in Partial Pressure of Oxygen (pO₂)
timeFrame: Baseline, immediately post, 30 minutes post
measure: Change in Partial Pressure of Carbon Dioxide (pCO₂)
timeFrame: Baseline, immediately post, 30 minutes post
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References: