Bed Bath With Auditory Hypnosis on ICU Patients

NCT07019467 | Not Yet Recruiting

• 2 other identifiers: Bntz2025Bath2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Care

Keywords

auditory hypnosis; bed bath; comfort; critical ill patients; ICU; physiological parameters

Outcome Measures

Primary Outcomes (10)

• 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.

  Before bed bath, immediately and 30 minutes after the bed bat

• 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).

  Before bed bath, immediately and 30 minutes after the bed bath

• Change in Heart Rate

  Heart rate (beats per minute) will be measured before bed bath, immediately after, and 30 minutes after.

  Baseline (pre-bed bath), immediately post-bed bath, and 30 minutes post-bed bath

• 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.

  Baseline, immediately post, and 30 minutes post-intervention

• Change in Respiratory Rate

  Respiratory rate (breaths per minute) will be assessed at baseline, immediately after, and 30 minutes after the bed bath.

  Baseline, immediately post, 30 minutes post

• Change in Body Temperature

  Body temperature (in degrees Celsius) will be recorded at three time points: before, immediately after, and 30 minutes after the bed bath.

  Baseline, immediately post, 30 minutes post

• Change in Peripheral Oxygen Saturation (SpO₂)

  SpO₂ will be measured using pulse oximetry before and after the bed bath at designated time points.

  Baseline, immediately post, 30 minutes post

• Change in Blood pH

  Blood pH will be assessed through arterial blood gas sampling at three time points.

  Baseline, immediately post, 30 minutes post

• Change in Partial Pressure of Oxygen (pO₂)

  pO₂ will be measured through arterial blood gas analysis at three time points.

  Baseline, immediately post, 30 minutes post

• Change in Partial Pressure of Carbon Dioxide (pCO₂)

  pCO₂ values will be obtained via arterial blood gas analysis at the specified intervals.

  Baseline, immediately post, 30 minutes post

Study Arms (2)

Bed bath with auditory hypnosis

EXPERIMENTAL

In the bed bath protocol accompanied by auditory hypnosis; An audio recording with 30-60 minutes of auditory hypnosis content specific to the ICU patient will be prepared with the support of an expert hypnotherapist. This audio recording will include the following messages: - The purpose of the bed bath, - Procedures to be performed during the bed bath, - Benefits of the bed bath, - Feeling safe during the bed bath, - Improvement of physiological parameters and comfort level after the bed bath.

Other: Bed Bath With Auditory Hypnosis

Control Group

NO INTERVENTION

In this study, the control group will receive standard bed bath.

Interventions

Bed Bath With Auditory Hypnosis OTHER

In 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.

Bed bath with auditory hypnosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Banu Terzi: lead

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Central Study Contacts

Banu Terzi, Assoc. Prof.

CONTACT

+90 242 2272974; banuterzi@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomised
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental, randomised controlled, single-blind study

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 13, 2025
• Study Start: June 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)