NCT05711706

Brief Summary

Surgical treatment is applied in 15% of individuals diagnosed with lumbar disc herniation. In this study, it was aimed to determine the effect of Su Jok application, which is one of the non-drug methods, in reducing or completely eliminating pain and anxiety after lumbar disc surgery and increasing the quality of recovery.The universe of the study, between November 2022 and June 2023, Istanbul Kartal Dr. Patients with lumbar disc surgery will be recruited in the Neurosurgery Clinic of Lütfi Kırdar City Hospital. Data will be obtained with Introductory Information Form, McGill Pain Scale Short Form (SF-MPQ), Visual Analog Scale (Visual Comparison Scale) (VAS), STAII State Anxiety Scale, Quality of Recovery Questionnaire (QOR-40). The individual who will undergo lumbar disc surgery will be visited in the clinic one day before the surgery and will be informed about the study. The sampled individuals will be included in the intervention and control groups using a random number table created with MS Excel software. Su Jok will be applied to the patients included in the intervention group at the third hour after the operation. Before the application, Quality of Recovery Questionnaire (QOR-40), McGill Pain Scale Short Form and STAII State Anxiety Scale will be administered. After the application, the pain levels of the patients will be re-evaluated with the Visual Analogue Scale (Visual Comparison Scale) (VAS) and their anxiety levels will be re-evaluated with the STAII State Anxiety Scale. On the first and second days after the surgery, the patients will be visited again in the clinic and the Quality of Healing Questionnaire (QOR-40), Visual Analog Scale (Visual Comparison Scale) (VAS) and STAII State Anxiety Scales will be administered before the Su Jok application, and then the Su Jok application will be repeated.After the application, the pain levels of the patients will be re-evaluated with the Visual Analogue Scale (Visual Comparison Scale) (VAS) and their anxiety levels will be re-evaluated with the STAII State Anxiety Scale. Patients will be interviewed again at the control appointment 10 days after discharge, and their quality of recovery will be determined using the Quality of Healing Questionnaire (QOR-40). In the control group, pain, anxiety and healing quality levels will be determined in the same periods without any application.

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 Mar 2023

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

First Submitted

Initial submission to the registry

November 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

November 28, 2022

Last Update Submit

March 22, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • The Effect of Su Jok Application on Pain

    Visual Analogue Scale:The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm).McGill Pain Scale Short Form (SF-MPQ):The scale will be used to determine the qualitative characteristics of pain in the initial pain assessment of patients. Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used in the pain assessment before and after the application.Post-Surgery.After Transfer to the Clinic:Patients who have undergone lumbar disc surgery will be visited at the clinic for Su Jok application at the 3rd hour after surgery,Before the Su Jok application, the patient's pain status will be determined with the SF-MPQ15 minutes after the Su Jok application, the patient's pain status will be determined by the Visual Analogue Scale (VAS). These stages will be applied again on the 1st and 2nd days after the surgery.

    12 month

  • The Effect of Su Jok Application on Anxiety

    State Anxiety Inventory: In our study, the "State Anxiety Inventory" will be used before and after the procedure to evaluate the anxiety levels of the patients in a certain situation.The "State Anxiety Inventory (STAI-I)" is a tool that measures how the individual feels at a particular moment and situation, that is, the level of anxiety in that condition. Post-Surgery - After Transfer to the Clinic: Before the Su Jok application, the patient's anxiety status will be determined by the State-Trait Anxiety Inventory (STAI-I),For 30 minutes, the point where the seed is fixed will be massaged with the Su Jok technique,15 minutes after the Su Jok application, the patient's pain status will be determined by the State-Trait Anxiety Inventory (STAI-I).These stages will be applied again on the 1st and 2nd days after the surgery.

    12 month

  • The Effect of Su Jok Application on Quality of Recovery

    The Quality of Healing-40 Scale (QoR-40) consists of five sub-dimensions and 40 items. The sub-dimensions of the scale are emotional state, physical comfort, patient support, physical independence and pain. with the individual.Post-Surgery - After Transfer to the Clinic:Before the Su Jok application, the quality of recovery of the patient will be determined by the Quality of Healing-40 Scale (QoR-40), which covers 24 hours. These stages will be applied again on the 1st -2nd days after the surgery and Postoperative 10th Day.

    12 month

Study Arms (2)

Su Jok Application

EXPERIMENTAL

I. Interview: One Day Before Surgery: II. Interview: Post-Surgery - After Transfer to the Clinic III. Interview: Postoperative Day 1 IV. Interview: Postoperative Day 2 V. Interview (Post-Operative Day 10

Other: Su Jok Application

Standard care

NO INTERVENTION

I. Interview: One Day Before Surgery: II. Interview: Post-Surgery - After Transfer to the Clinic III. Interview: Postoperative Day 1 IV. Interview: Postoperative Day 2 V. Interview (Post-Operative Day 10

Interventions

Su Jok massage appplication

Su Jok Application

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone lumbar disc surgery under general anesthesia
  • years old and over,
  • At least 3 hours have passed from the analgesic administration,
  • Patients willing to participate in the study will be included in the study.

You may not qualify if:

  • Loss of sensation, amputation, injury, etc., which will prevent application in hands. the one which,
  • Patient-controlled analgesia (PCA) is applied,
  • Over 70 years old,
  • Using anxiolytic and sedative drugs,
  • Having a psychiatric illness,
  • Those who lost their lives after the operation,
  • Unstable hemodynamic status,
  • Patients with a hospital stay of less than 72 hours (due to Su Jok application for 3 days) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niran COBAN

Istanbul, 34104, Turkey (Türkiye)

Location

Related Publications (7)

  • Özbayır, T. (2011). (in) Nörolojik Travmalar, Karadakovan, A. ve Eti Aslan, F. (Ed.), Dahili ve Cerrahi Hastalıklarda Bakım, Adana: Nobel Kitabevi, 2. Baskı: 1280-1284.

    BACKGROUND
  • Lurie JD, Tosteson TD, Tosteson AN, Zhao W, Morgan TS, Abdu WA, Herkowitz H, Weinstein JN. Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial. Spine (Phila Pa 1976). 2014 Jan 1;39(1):3-16. doi: 10.1097/BRS.0000000000000088.

    PMID: 24153171BACKGROUND
  • Woo, PJ. Kendi Kendine Su Jok Doktor. İstanbul: Vesta Ofset Matbaacılık, 2010.

    BACKGROUND
  • Ivanov, P. (2018). Su Jok and Moxa. A Self-Trea a Self-Treatment Manual. Lavcıel, H.(edt). Bulgaria:MEDIKS Ltd

    BACKGROUND
  • Woo, J. W. (1987). Be Your Own Doctor. India: Smile Academy.

    BACKGROUND
  • Cruz, JC.P, Sotelo Matos, AM., Castaigne, YF., Pérez, AMP. Su-Jok Therapy for Cervicalgia Treatment. Correo Científico Médico de Holguín. 2018;4.

    BACKGROUND
  • Rodríguez, AC, Mendoza, YA, García, EFC, Castañeda YT. (2018). Su-Jok therapy in patients with cervicalgia diagnosis. Facultad de Tecnología de la Salud. 9(3):42-49.

    BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Niran COBAN

    https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

    STUDY DIRECTOR

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
SPONSOR INVESTIGATOR
PI Title
Lecturer, Doctor

Study Record Dates

First Submitted

November 28, 2022

First Posted

February 3, 2023

Study Start

March 10, 2023

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations