NCT06502132

Brief Summary

The aim of this study is to examine the effect of therapeutic touch and patient education on anxiety, pain, satisfaction levels and physiological parameters of patients and to determine patient experiences. The study will be conducted as a mixed method study. In the study, the effects of therapeutic touch and patient education on anxiety, satisfaction, pain levels and physiological parameters will be compared and the results will be compared. At the same time, qualitative statements of patients will be analyzed in depth and quantitative data will be supported.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable surgery

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

July 3, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2024

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

July 5, 2024

Last Update Submit

February 3, 2025

Conditions

Keywords

surgerypostponementanxietypain

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI-TX)

    The 4-point Likert-type scale consists of two sections, each with 20 questions. The total score that can be obtained from the scale varies between 20 and 80, with a low average score indicating low anxiety and a high average score indicating high anxiety. There are ten reverse items in the State Anxiety Scale (1st, 2nd, 5th, 8th, 20th, 22nd, 25th, 26th, 19th and 20th), and seven reverse items in the Trait Anxiety Scale (21st, 26th, 37th, 30th, 33rd, 36th and 39th). The total score is calculated by subtracting the total weighted score of the reverse items from the total weighted score obtained for the direct items.

    pre-test: 10 min;post-test: 5 min

Secondary Outcomes (2)

  • Numeric Rating Scale (NRS)

    Pre-test: Administered when the patient is informed about the postponement of the surgery (5 seconds for the patient to answer). Post-test: administered again 1 hour after the pre-test is completed (patient responds in 5 seconds).

  • Patient Satisfaction Evaluation Form According to Watson Improvement Processes

    5 min

Study Arms (3)

Control Group

NO INTERVENTION

Control group patients will receive routine care and no other intervention will be made within the scope of the study.

Patient Education Group

ACTIVE COMPARATOR

The patient education group will be informed about the waiting process that occurs as a result of surgery postponement through an education booklet prepared by the researcher in line with the literature.

Other: Patient Education Group

Therapeutic Touch Group

ACTIVE COMPARATOR

During the waiting period, patients will receive therapeutic touch by a certified researcher.

Other: Therapeutic Touch Group

Interventions

Patients whose surgery has been postponed will be educated by the researcher through a booklet regarding the waiting process. The education includes information such as anxiety management, pain management, and re-surgery planning. The booklet consists of 22 pages and a copy is given to each patient in this group. The education lasts between 15-20 minutes and the patients' questions are answered. It is applied in a single session.

Patient Education Group

Therapeutic touch application is applied as a single session and lasts approximately 20-25 minutes. The therapeutic touch that emerges from the artistic aspect of nursing is an energybased practice that does not involve physical contact. Therapeutic touch is a conscious and compassionate effort to direct the flow of one's universal life energy to healing by influencing this energy.

Therapeutic Touch Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 years of age or olde
  • To undergo surgery
  • Postponement of the operation for 24 hours
  • Being able to read, write and communicate in Turkish
  • Not having any vision, hearing or speech problems
  • Volunteering to participate in the study

You may not qualify if:

  • Being under 18 years of age
  • Complete cancellation of the operation
  • Postponing the operation for more than 24 hours
  • Having vision, hearing or speech problems that prevent communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Health Sciences Institute

Erzurum, Yakutiye, 25030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three groups with two experimental groups and one control group, including patient education and therapeutic touch
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 16, 2024

Study Start

July 3, 2024

Primary Completion

August 5, 2024

Study Completion

December 27, 2024

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations