Effects of Acupressure Applied to Intensive Care Patients on Physiological Parameters, Pain, Sleep Quality, Anxiety and Perception of Nursing Presence

NCT ID: NCT06994715

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-31

Brief Summary

This study will be conducted in a randomized controlled experimental design to examine the effects of acupressure applied to patients treated in the intensive care unit on physiological parameters, pain, sleep quality, anxiety and perception of nurse presence. The study will be conducted with 60 patients (20 intervention, 20 placebo, 20 control groups) treated in the 2nd stage Intensive Care Unit of an University Hospital between May 2025 and January 2026. Acupressure will be applied to the intervention group for 2 days, morning and evening, for four sessions. For four sessions, pseudo acupressure will be used on the placebo group for 2 days, morning and evening. No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Glasgow Coma Scale (GCS), Visual Assessment Scale (VAS), Physiological Parameter Assessment Form, Richards-Campbell Sleep Scale, Spielberg State-Trait Anxiety Inventory, and Nurse Presence Scale (PONS).

Conditions

Acupressure; Intensive Care Unit; Anxiety; Nursing Presence; Sleep Quality; Physiological Parameters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Application group

After the purpose of the study and the method of application are explained to the intensive care patients, the "Introductory Information Form", "Glasgow Coma Scale", "Visual Assessment Scale", "Physiological Parameters Assessment Form", "Richards-Campbell Sleep Scale", "Nursing Presence Scale" and "Spielberg State-Trait Anxiety Scale" will be applied. A total of 8 sessions of acupressure will be applied morning and evening for 2 days. The measurements will be repeated afterwards.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: OTHER

The patient will be placed in a suitable position (supine) or alternatively in a side-lying position, and the patient's privacy will be taken into account to determine the pressure points. The patient's own finger measurement will be taken into account when determining the pressure points. Acupressure points will be marked using a surgical marking pen. The pressure will be applied manually. The thumb will be used for this. Before applying direct pressure to the point, a light rubbing movement will be made for approximately 15 seconds on the point area to reduce tension and tissue sensitivity, to warm, relax and prepare. Approximately 2 minutes of pressure will be applied to each point in a circular manner. Each application will last approximately 18 minutes. The patient will be measured 9 times in total during 4 sessions.

Placebo Group

After the purpose of the study and the method of application are explained to the intensive care patients, the "Introductory Information Form", "Glasgow Coma Scale", "Visual Assessment Scale", "Physiological Parameters Assessment Form", "Richards-Campbell Sleep Scale", "Nursing Presence Scale" and "Spielberg State-Trait Anxiety Scale" will be applied. A total of 8 sessions of pseudo acupressure will be applied morning and evening for 2 days. Only light pressure will be applied without massage 2 cm to the side of the real points. The procedure will be performed with gloves. The measurements will be repeated afterwards.

Group Type: PLACEBO_COMPARATOR

pseudo acupressure

Intervention Type: OTHER

A pseudo acupressure will be applied to the patients in the supine or side-lying position. The researcher will perform this application by wearing gloves. Wearing gloves will reduce the therapeutic interaction with the patient. Since applying pressure or circular rubbing movements to patients may enter the area where other meridians pass and create a different effect, it will be waited for 2 minutes without applying any pressure or rubbing movements on the bone protrusions where the meridian does not pass and where there are no active pressure points. The application will be determined to be approximately 2 cm away from the acupressure points. The application will again be done manually with the thumb. Each application will take approximately 18 minutes. 4 sessions of application and a total of 9 measurements will be made to the patients.

Control Group

No application will be made to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupressure

The patient will be placed in a suitable position (supine) or alternatively in a side-lying position, and the patient's privacy will be taken into account to determine the pressure points. The patient's own finger measurement will be taken into account when determining the pressure points. Acupressure points will be marked using a surgical marking pen. The pressure will be applied manually. The thumb will be used for this. Before applying direct pressure to the point, a light rubbing movement will be made for approximately 15 seconds on the point area to reduce tension and tissue sensitivity, to warm, relax and prepare. Approximately 2 minutes of pressure will be applied to each point in a circular manner. Each application will last approximately 18 minutes. The patient will be measured 9 times in total during 4 sessions.

Intervention Type: OTHER

pseudo acupressure

A pseudo acupressure will be applied to the patients in the supine or side-lying position. The researcher will perform this application by wearing gloves. Wearing gloves will reduce the therapeutic interaction with the patient. Since applying pressure or circular rubbing movements to patients may enter the area where other meridians pass and create a different effect, it will be waited for 2 minutes without applying any pressure or rubbing movements on the bone protrusions where the meridian does not pass and where there are no active pressure points. The application will be determined to be approximately 2 cm away from the acupressure points. The application will again be done manually with the thumb. Each application will take approximately 18 minutes. 4 sessions of application and a total of 9 measurements will be made to the patients.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have received intensive care treatment for at least 48 hours,
• Are 18 years of age or older,
• Have a Glasgow Coma Scale score of >13,
• Can speak and write in Turkish,
• Have no psychiatric diagnosis,
• Have no communication problems,
• Have a VAS score of ≥1,
• Have a mean arterial pressure of ≥65,
• Have SpO2 of ≥85.

Exclusion Criteria

Have previously received acupressure treatment,

• Have ulcers, necrotic tissue and signs and symptoms of infection at the points where pressure will be applied,
• Have used antihypertensives, beta-blockers and similar medications,
• Have sedation,
• Have respiratory support from the device,
• Have inotropic treatment (dopamine, steradin and others),
• Have analgesic treatment in their routine treatment will not be included in the study.

Patients who were discharged during the study,

• Patients who died during the study,
• Patients who wanted to leave the study,
• Patients who started receiving sedation during the application,
• Patients who added antihypertensive, beta-blocker and similar drugs to their routine treatment during the application,
• Patients who received inotropic treatment (dopamine, steradin and others) during the application,
• Patients who started receiving analgesia treatment during the application,
• Patients who developed ulcers, necrotic tissue and infection at the points where pressure will be applied during the application,
• Patients who started receiving respiratory support from the device during the application,
• Patients who had a Glasgow Coma Scale score of ≤13, mean arterial pressure of ≤65 and SpO2 of ≤85 during the application will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Canbolat

Gazi University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ozlem Canbolat

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ozlem Canbolat

Role: CONTACT

ozlemcanbolat@gazi.edu.tr

+90 312 216 26 86

Facility Contacts

Ozlem Canbolat

Role: primary

ozlemcanbolat@gazi.edu.tr

05056439381

Ozlem Canbolat

Role: backup

Other Identifiers

E-77082166-302.08.01-1229645

Identifier Type: -

Identifier Source: org_study_id