NCT07031271

Brief Summary

The aim of this study was to investigate the effects of playing tangram game after surgery on pain, fatigue and comfort levels in patients undergoing abdominal surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 13, 2025

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Pain level

    The numerical rating scale to be used in the assessment of pain is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "no pain", corresponding to 0 points, and the upper end is "unbearable pain", corresponding to 10 points. As the pain intensity expressed by the patient increases on the scale, it will be interpreted that the patient's pain increases. This is first measurement.

    Postoperative 1st day

  • Pain level

    The numerical rating scale to be used in the assessment of pain is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "no pain", corresponding to 0 points, and the upper end is "unbearable pain", corresponding to 10 points. As the pain intensity expressed by the patient increases on the scale, it will be interpreted that the patient's pain increases. This is second measurement.

    20 minutes later after first measurement

  • Pain level

    The numerical rating scale to be used in the assessment of pain is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "no pain", corresponding to 0 points, and the upper end is "unbearable pain", corresponding to 10 points. As the pain intensity expressed by the patient increases on the scale, it will be interpreted that the patient's pain increases. This is third measurement.

    30 minutes later after second measurement

  • Fatigue level

    The numerical rating scale to be used in the assessment of fatigue is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "not tired" corresponding to 0 points, and the upper end is "unbearably tired" corresponding to 10 points. As the fatigue intensity expressed by the patient increases on the scale, it will be interpreted as the patient's fatigue increasing. This is first mesurement.

    Postoperative 1st day

  • Fatigue level

    The numerical rating scale to be used in the assessment of fatigue is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "not tired" corresponding to 0 points, and the upper end is "unbearably tired" corresponding to 10 points. As the fatigue intensity expressed by the patient increases on the scale, it will be interpreted as the patient's fatigue increasing. This is second mesurement.

    20 minutes later after fist measurement

  • Fatigue level

    The numerical rating scale to be used in the assessment of fatigue is a one-dimensional 10 cm scale based on the patient's self-report. The lower end is "not tired" corresponding to 0 points, and the upper end is "unbearably tired" corresponding to 10 points. As the fatigue intensity expressed by the patient increases on the scale, it will be interpreted as the patient's fatigue increasing. This is third mesurement.

    30 minutes later after second measurement

Secondary Outcomes (1)

  • Comfort level

    30 minutes after second measurement

Study Arms (2)

Tangram game

EXPERIMENTAL

In this group, researchers will apply the Patient Identification Form to patients who are on the first day after surgery, who give at least 2 points for pain level, and who have had at least 3 hours since the last analgesic application, and will ask about the patients' pain and fatigue levels (First measurement). After this evaluation, patients in the intervention group will be asked to play the game for 20 minutes by making their own models with 7-piece tangram pieces in accordance with the randomization output. After the game, the pain and fatigue levels will be questioned again (Second measurement). The pain and fatigue levels will be questioned again 30 minutes after the second measurement (Third measurement).

Behavioral: Tangram game

Usual care

NO INTERVENTION

In this group, researchers will apply the Patient Identification Form to patients who are on the first day after surgery, who give at least 2 points for pain level, and who have had at least 3 hours since the last analgesic application, and will ask about the patients' pain and fatigue levels (First measurement). After this assessment, no intervention will be applied to the patients, and the pain and fatigue levels will be questioned again 20 minutes after the first measurement (Second measurement). The pain and fatigue levels will be questioned again 30 minutes after the second measurement (Third measurement).

Interventions

Tangram gameBEHAVIORAL

Tangram game; It is a very old intelligence and attention game of Chinese origin. This game stands out with its both entertaining and educational aspects. Tangram consists of seven geometric pieces formed from a square shape. These 7 pieces; 2 large right triangles, 1 medium right triangle, 2 small right triangles, 1 square and 1 parallelogram. The aim is to create various shapes (animals, people, objects, letters, etc.) with these pieces. The aim of the Tangram game is to recreate the same appearance with a given shape (silhouette) using the pieces. All 7 pieces must be used in the game, the pieces must not be overlapped, the pieces must not be cut or divided, the pieces can be rotated or turned according to the selected shape. For example, the person is asked to create a cat figure with these 7 pieces in accordance with the rules. This game is one of the non-pharmacological pain management techniques by diverting the attention of the patients. It is easy to apply and cheap.

Tangram game

Eligibility Criteria

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

You may qualify if:

  • Having had abdominal surgery
  • Being on the first day after surgery
  • Having a first pain measurement score of at least 2
  • Having at least 3 hours since the last analgesic application

You may not qualify if:

  • Having hearing/vision/mental problems
  • Having limited movement in the hand/wrist/arm
  • Having undergone surgery due to cancer
  • Being diagnosed with a psychological illness (schizophrenia, depression)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Assisstant (Principal Investigator)

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 22, 2025

Study Start

June 15, 2025

Primary Completion

December 15, 2025

Study Completion

May 15, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
CSR
Time Frame
12 months after publication
Access Criteria
Relevance to the topic of the study and approval of all-authors within 1 month of receiving the request.

Locations