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Su Jok Application in After Lumbar Disc Surgery

Primary Purpose

Pain, Postoperative, Lumbar Disc Herniation, Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Su Jok Application
Sponsored by
Niran Çoban
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Having undergone lumbar disc surgery under general anesthesia 18 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. Exclusion Criteria: • 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, Patients with communication barriers will not be included in the study. Exclusion Criteria 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.

Sites / Locations

  • Niran COBAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Su Jok Application

Standard care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
January 25, 2023
Sponsor
Niran Çoban
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1. Study Identification

Unique Protocol Identification Number
NCT05711706
Brief Title
Su Jok Application in After Lumbar Disc Surgery
Official Title
The Effect of Su Jok Application on Pain, Anxiety and Quality of Recovery After Lumbar Disc Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 10, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Niran Çoban

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Chronic low back pain has become a common problem today and is seen as a phenomenon that directly affects the daily life of individuals and, in parallel, affects their psychological and socioeconomic status. There are many causes of back pain. The most common problem among these is Lumbar disc herniation (LDH). LDH, which causes low back pain, is a condition in which the nucleus pulposus degenerates the annulus and causes herniation and pain as a result of the deterioration of the structure of the lower lumbar vertebrae that carry the weight of the trunk. Surgical treatment is applied in 15% of individuals diagnosed with LDH. Postoperative nursing care is based on interventions for ensuring homeostasis, preventing the re-development of herniation, preventing complications and early diagnosis, and enabling the patient to perform daily life activities. Post-operative pain affects all systems, prolonging the patient's recovery period and prolonging their quality of life.In pain management, it is essential to try to control it with the aim of preventing and eliminating pain. In addition to being an effective method, pharmacological methods are also reported to be effective in non-pharmacological methods such as relaxation exercises, elimination of painful stimuli, position, touch, and speaking. The role of the nurse in controlling pain is quite large. For this reason, it is necessary to have high-level pain control knowledge by educating himself on non-pharmacological methods . One of the non-pharmacological methods is Su Jok, which is a massage technique. Su Jok is explained by the principle of the "fitness system", in which the hands and feet are a miniature replica of the body. There are tiny swellings called "ball conformity" on the reflection points of the hands and feet of the organ where the disease occurs.As a result of the pressure massage applied to the area where the swelling is located, pain and withdrawal sensation occur in the application area. This feeling shows that the right point for application has been determined . "Diagnostic probe" or "diagnostic stick" is used to determine the correct point.After the correct point is determined, these points are stimulated by using various applicators (rings, metal starlets, magnets, seeds, etc.) and appropriate plant seeds, and the energy flow is maintained. Massage with seeds are the most commonly used natural applicators for Su Jok massage application. Since seeds give life to plants, it is argued that there is a great energy inside them and this energy is a life-giving source that is in constant exchange with the external environment. The application is in the form of massaging the seeds suitable for the determined point on the hand and foot by fixing them with a plaster.The period of use of seeds can last from several hours to a day; For long-term use, daily seed change is required. It is ensured that the applied seed is massaged at certain intervals. Thanks to the door control mechanism, the pain sensation is eliminated with the applied seed massage. Since Su Jok application does not cause any side effects, it can be used in all age groups; The time to create a positive effect can vary from a few minutes to a few days. This application can be used in acute and chronic pain complaints.Although there are limited studies in the literature on Su Jok massage, Cruz and Munoz (2012) reported a decrease in pain frequency and severity as a result of the study conducted with patients with tension-type headache. Gonzales et al. (2011) applied Su Jok to patients with carpal tunnel syndrome and reported a reduction in pain and other symptoms as a result . In another study in which Su Jok massage was applied to cesarean section patients, it was found that the postoperative Su Jok application reduced the level of pain . There is no educational background required for the Su Jok massage application. Anyone who receives training can perform Su Jok massage . After receiving Su Jok training, each individual can manage their pain with this massage technique. When the literature is examined, it is seen that the studies on the application of Su Jok massage are limited. Especially the pain experienced in the post-operative period increases the anxiety level of individuals and affects the healing process. Therefore, it is aimed to eliminate the pain with the Su Jok massage application. In this study, it is aimed to determine the effect of Su Jok massage, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Lumbar Disc Herniation, Surgery, Nurse's Role

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Su Jok Application
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Su Jok Application
Intervention Description
Su Jok massage appplication
Primary Outcome Measure Information:
Title
The Effect of Su Jok Application on Pain
Description
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.
Time Frame
12 month
Title
The Effect of Su Jok Application on Anxiety
Description
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.
Time Frame
12 month
Title
The Effect of Su Jok Application on Quality of Recovery
Description
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.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Having undergone lumbar disc surgery under general anesthesia 18 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. Exclusion Criteria: • 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, Patients with communication barriers will not be included in the study. Exclusion Criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niran COBAN
Phone
05301586912
Email
nirancoban@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Niran Çoban
Phone
05301586912
Email
nirancoban@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niran COBAN
Organizational Affiliation
https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
Official's Role
Study Director
Facility Information:
Facility Name
Niran COBAN
City
Istanbul
ZIP/Postal Code
34104
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
24153171
Citation
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. Erratum In: Spine (Phila Pa 1976). 2015 Jan;40(1):E59.
Results Reference
background
Citation
Woo, PJ. Kendi Kendine Su Jok Doktor. İstanbul: Vesta Ofset Matbaacılık, 2010.
Results Reference
background
Citation
Ivanov, P. (2018). Su Jok and Moxa. A Self-Trea a Self-Treatment Manual. Lavcıel, H.(edt). Bulgaria:MEDIKS Ltd
Results Reference
background
Citation
Woo, J. W. (1987). Be Your Own Doctor. India: Smile Academy.
Results Reference
background
Citation
Cruz, JC.P, Sotelo Matos, AM., Castaigne, YF., Pérez, AMP. Su-Jok Therapy for Cervicalgia Treatment. Correo Científico Médico de Holguín. 2018;4.
Results Reference
background
Citation
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.
Results Reference
background

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Su Jok Application in After Lumbar Disc Surgery

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