The Effect of Therapeutic Touch Applied During Knee Replacement Surgery on Anxiety, Vital Signs and Comfort Level

NCT06426381 | Completed

• 1 other identifier: ayse25
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of therapeutic touch on patients' anxiety, vital signs and comfort levels during knee replacement surgery performed under local anesthesia. The study will be completed with a total of 128 participants, including 64 experimental and 64 control participants. As a randomization method, the simple randomization method will be used to ensure an equal number of samples in two groups, and patients will be assigned to the experimental and control groups. In the research, patients will be given verbal information about the research, and written informed consent will be obtained from the patients who accept it. In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery and the effect of this application on vital signs, anxiety level and comfort was evaluated.

Conditions

Intraoperative Complications

Keywords

therapeutic touch; anxiety; comfort

Outcome Measures

Primary Outcomes (4)

• Patient Introduction Form

  The survey form, created by the researcher by scanning the literature on the subject, consists of a total of 13 questions including questions about gender, age, place of residence, education, status, profession, marital status, and total knee replacement surgery.

  up to 24 weeks

• Vital Signs Record Form

  An observation form was used to observe the patients in the experimental and control groups to whom therapeutic touch was applied during surgery. This form was used to record the duration of therapeutic touch, respiration, oxygen saturation, pulse, systolic blood pressure, and diastolic blood pressure.

  up to 24 weeks

• Spielberg State-Trait Anxiety Scale

  There are 4 different options in the section that the individuals to whom the scale is applied will mark. These options consist of "not at all", "somewhat", "a lot" and "completely" in order to determine the intensity of the expressed behaviors and emotions. The total score obtained from both scales varies between 20-80. High scores indicate high anxiety levels, low scores indicate low anxiety levels. There are two types of statements in the State-Trait Anxiety Scale. Direct expressions express negative emotions, while inverted expressions express positive emotions. The reversed expressions in the State Anxiety Scale are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The reversed expressions in the Trait Anxiety Scale constitute items 26, 27, 30, 33, 36 and 39. After finding the total weights of direct and reverse expressions separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions.

  Before and after surgery

• Perianesthesia Comfort Scale (PCS)

  The scale consists of 24 items that reflect the individual's general thought process before and after the surgical intervention and question his/her self-conception and feelings. Each statement in the scale has a Likert-type scoring ranging from 1 to 6, from "strongly disagree" to "strongly agree". The response patterns of the scale, which consists of positive and negative items, are given in mixed order. 12 of the statements are positive (1.5, 6, 11, 14, 16, 18, 19, 20, 21, 23, 24), 12 are negative (2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 17, 22); Negative statements are reversed in scoring. Accordingly, in positive statements, a high score (6) indicates high comfort, a low score (1) indicates low comfort, and in negative items, a low score (1) indicates high comfort and a high score (6) indicates low comfort.

  up to 24 weeks

Study Arms (2)

There is therapeutic touch

EXPERIMENTAL

Patients will be administered an Introduction Form and Spielberg State-Trait Anxiety Scale before surgery. The Vital Signs Record Form will be filled out on the patient's operating table. Then, therapeutic touch will be applied for 15-20 minutes during the surgery. After the procedure, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered.

Behavioral: Therapeutic Touch

No therapeutic touch

NO INTERVENTION

An Introduction Form and the Spielberg State-Trait Anxiety Scale will be administered to the patients. When you are taken to the operating table, a Vital Signs Record Form will be filled out. After the procedure is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale (PCS) will be administered.

Interventions

Therapeutic Touch BEHAVIORAL

Asymmetric energy fields can be balanced using the therapeutic touch method and treatment becomes easier. In this way, the person regains his health or can be helped to regain his health.

There is therapeutic touch

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 18-85
• No communication problems (speaks Turkish)
• No vision or hearing problems
• No cognitive problems
• The patient agrees to participate in the study
• Having knee replacement surgery with local anesthesia

You may not qualify if:

• Being under the age of 18 and over the age of 85
• Having a communication problem (does not speak Turkish)
• The patient wants to leave the study
• Not agreeing to participate in the research
• Not being at a cognitive level to answer the questions asked.
• Patients with vision and hearing problems
• Having knee replacement surgery with general anesthesia

Sponsors & Collaborators

• Dilek GÜRÇAYIR: lead

Study Sites (1)

Ayşe ÇELİK

Palandöken, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Complications; Anxiety Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Dilek GÜRÇAYIR, Dr.

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Academician

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 23, 2024
• Study Start: October 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

TU (1)