NCT07632781

Brief Summary

The aim of this study is to examine the effect of Su Jok Therapy, applied to patients receiving mechanical ventilation support in the intensive care unit, on pain and physiological parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

December 30, 2025

Last Update Submit

June 2, 2026

Conditions

Keywords

SU-JOK THERAPYIntensive Care UnitpainPHYSIOLOGICAL PARAMETERS

Outcome Measures

Primary Outcomes (7)

  • Systolic Blood Pressure

    Hemodynamic response measured by systolic blood pressure

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Heart Rate (Pulse Rate)

    Heart rate measured in beats per minute

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Oxygen Saturation (SpO₂)

    Peripheral oxygen saturation

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Body Temperature

    Core body temperature

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Respiratory Rate

    Number of breaths per minute

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Richmond Agitation-Sedation Scale (RASS)

    Negative scores indicate sedation, positive scores indicate agitation

    baseline, 1 hour, 4 hours after intervention

  • Behavioral Pain Scale (BPS)

    Higher scores indicate more severe pain

    baseline, 1 hour, 4 hours after intervention

Secondary Outcomes (8)

  • Hemodynamic Stability Index (Systolic/Diastolic Blood Pressure Change)

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Oxygenation Trend (SpO₂ Change Over Time)

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Heart Rate Variability (Clinical Pulse Trend)

    baseline, 15 minutes, 60 minutes, 4 hours after intervention

  • Sedation-Agitation Level Stability (RASS Trend)

    baseline, 1 hour, 4 hours after intervention

  • Pain Intensity Change (Behavioral Pain Scale Trend)

    baseline, 1 hour, 4 hours after intervention

  • +3 more secondary outcomes

Study Arms (3)

Intervetion group

EXPERIMENTAL

In the intervention group, su-jok seed therapy will be applied to the su-jok reflection zones on the hands.

Other: su jok therapy group

Placebo group

PLACEBO COMPARATOR

In the placebo group, su-jok seed therapy will be applied to areas on the hands that are different from the reflection zones.

Other: Placebo Group

Control group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

In the intervention group, the reflex zones on the hands were identified with a probe. Buckwheat seeds were fixed to these areas with adhesive tape and massaged. The seeds remained in place for 4 hours. After 2 hours, these areas were stimulated with a 1-2 minute massage. Measurements were recorded on a data collection form. The application was carried out for 3 days.

Intervetion group

In the placebo group, reflex zones on the hand were identified using a probe. Buckwheat seeds were fixed to a different area near these zones with a seed patch and massaged. The seeds remained in place for 4 hours. After 2 hours, these areas were stimulated with a 1-2 minute massage. Measurements were recorded on a data collection form. The application was carried out for 3 days.

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Patients who are in intensive care,
  • Patients receiving IMV support,
  • Patients who were admitted to the ICU from the start date of the study and are planned to be monitored for at least 24 hours,
  • Patients without any problems in the area where Su-Jok will be applied,
  • Patients with GCS \> 3, RASS between +1 and +4, BPS \> 3

You may not qualify if:

  • Patients in the ward,
  • Patients with any problems such as fungal infections or wounds in the area where Su Jok will be applied,
  • Patients with a GCS of 3,
  • Patients not receiving IMV support will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş

Kahramanmaraş, Kahramanmaraş, 46050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • NERMİN OLGUN, Prof. Dr.

    Hasan Kalyoncu University

    STUDY CHAIR
  • MELTEM KALAYCI

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

December 30, 2025

First Posted

June 8, 2026

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

November 1, 2025

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations