NCT06994715

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

May 20, 2025

Last Update Submit

March 18, 2026

Conditions

Keywords

Acupressureintensive care unitanxietynursing presencesleep qualityphysiological parameters

Outcome Measures

Primary Outcomes (4)

  • Visual Assessment Scale

    VAS is a measurement tool frequently used in the clinic for pain assessment. The ruler, which is indicated as 0-10 cm or 0-100 mm, has no pain (0) written on one end and the most severe pain (10) on the other end. It is scored between 0-10. The patient marks the point on the ruler where he feels the pain.

    1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application

  • Spielberg State-Trait Anxiety Scale

    The scale consists of two sub-dimensions measuring continuous and state anxiety. There are 20 questions for each sub-dimension on a 4-point Likert scale (not at all = 1, a little = 2, a lot = 3, completely = 4). The minimum-maximum score range that can be obtained from the scale varies between 20-80. Increasing scores on the scale indicate an increase in the level of anxiety.

    1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application and third day morning.

  • Physiological Parameters Assessment Form

    Systolic Blood Pressure (mm/Hg), Diastolic Blood Pressure (mm/Hg), Respiratory Rate, Heart Rate (Pulse) (beats/min) and Saturation parameters measured before and after acupressure of the intervention and placebo groups will be recorded. Systolic blood pressure measurements will be averaged. Diastolic blood pressure measurements will be averaged. Saturation measurements will be averaged. Respiratory rate measurements will be averaged. Heart Rate (Pulse) measurements will be averaged.

    1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application

  • Nursing Presence Scale

    The scale designed as a 5-point Likert is scored as follows; (never: 1 point), (rarely: 2 points), (occasionally/sometimes: 3 points), (frequently: 4 points) and (always: 5 points). The minimum and maximum scores that can be obtained from the scale are calculated between 24-120. An increase in the score obtained from the scale means that the behaviors in which the patient presents the presence of the nurse have increased and that the patient perceives these behaviors positively.

    1st day 15 minutes before application and third day morning.

Secondary Outcomes (1)

  • Richards-Campbell Sleep Scale

    1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application and third day morning.

Study Arms (3)

Application group

EXPERIMENTAL

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.

Other: Acupressure

Placebo Group

PLACEBO COMPARATOR

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.

Other: pseudo acupressure

Control Group

NO INTERVENTION

No application will be made to the control group.

Interventions

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.

Application group

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.

Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozlem Canbolat

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Mental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

May 1, 2025

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations