NCT07194252

Brief Summary

This randomized controlled study will investigate the effects of guided imagery on preoperative anxiety and postoperative pain and analgesic consumption in patients undergoing total joint arthroplasty. Conducted between September 2025 and June 2026 at a public hospital in Zonguldak, Turkey, the study will include patients scheduled for total joint arthroplasty following ethics committee approval. The intervention group will receive guided imagery twice preoperatively and once daily at 48 and 72 hours postoperatively. Outcomes will be assessed using the Surgical Anxiety Scale, surgery-specific anxiety scale, Numerical Rating Scale (NRS), and analgesic consumption tracking.

Trial Health

63
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Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress83%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

September 10, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2026

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 10, 2025

Last Update Submit

September 18, 2025

Conditions

Keywords

painanxietyanalgesictotal joint arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Surgical Anxiety Scale

    The scale was developed in Turkish by Karanci and Dirik (2003) and is a 5-point Likert-type scale (1: Strongly disagree, 5: Strongly agree). The scale consists of 10 statements covering fears that patients may experience regarding surgery. The maximum score that can be obtained from the scale is 50. High scores on the scale reflect anxiety about experiencing pain, dying during surgery, and complications and restrictions that may arise after surgery. The Cronbach's Alpha coefficient for the scale was found to be 0.79.

    September 2025-June 2026 (9 months)

Secondary Outcomes (2)

  • Numerical Rating Scale

    September 2025-June 2026 (9 months)

  • Analgesic Consumption Tracking Form

    September 2025-June 2026 (9 months)

Study Arms (2)

intervention Grubs

EXPERIMENTAL

The intervention group's surgical anxiety levels were assessed using the "Surgical Anxiety Scale" during the preoperative period. Subsequently, at the relevant clinic, the scale was administered twice on the day before the scheduled surgery date (at noon and in the evening) and once each at 48 and 72 hours post-surgery, for a total of four times. At the end of the application, the "Surgical Anxiety Scale" and the "Surgical-Specific Anxiety Scale" will be reapplied to the intervention group. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 hours postoperatively before the intervention, immediately after the intervention, and at 72 hours before the intervention and immediately after the intervention.

Other: Guided imagery technique application

Control Grubs

NO INTERVENTION

During the preoperative period, nursing care will be provided according to the routine care protocol of the clinic where the study is conducted. Subsequently, participants' levels of surgical anxiety will be assessed using the "Anxiety Scale Specific to Surgery" simultaneously with the intervention group patients. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 and 72 hours postoperatively and will be measured again 60 minutes after the measurements (simultaneously with the intervention group patients). In the final stage, the analgesic consumption of the intervention and control groups will be evaluated on the 2nd and 3rd days of the postoperative period using the "Analgesic Consumption Tracking Form" to assess the administration status of the analgesic drugs included in the treatment protocol, and the application phase of the study will be completed.

Interventions

Intervention is a guided imagery technique designed for patients undergoing total joint arthroplasty. It will be administered in a total of 4 sessions: once daily on the day before surgery, twice daily on the day of surgery, and once daily on the 2nd and 3rd days after surgery, accompanied by imagery scenarios developed in accordance with the Compact Disc (CD) and literature developed by the Turkish Psychological Association. The study aims to examine its effects on surgical anxiety levels, postoperative pain intensity, and analgesic consumption. This approach is structured as a non-pharmacological method specific to surgical nursing practice and differs from previous similar studies in that it is applied in both the preoperative and postoperative periods using the same sample in the literature.

intervention Grubs

Eligibility Criteria

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

You may qualify if:

  • Patients who have undergone unilateral arthroplasty surgery,
  • Without cognitive impairment,
  • Who speak and write Turkish,
  • Without hearing or vision problems,
  • Without any other acute illness causing pain or anxiety,
  • Who received the same analgesic agent in the treatment protocol during the postoperative period,
  • And who volunteered to participate in the study will be included.

You may not qualify if:

  • Having a diagnosis of chronic pain syndrome or neuropathic pain,
  • Having a diagnosis of psychiatric illness/being under treatment
  • Continuous use of analgesic/sedative medication that may affect the pain threshold,
  • Hearing impairment or severe cognitive impairment that prevents participation in guided imagery applications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Atatürk State Hospital

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Gülay YAZICI, Assoc. Prof.

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Central Study Contacts

Büşra ERGEN TURAN, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 26, 2025

Study Start

September 22, 2025

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

June 22, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations