NCT07137000

Brief Summary

With the development of modern techniques, art has become important in the provision of health services and has enabled individuals to better recognise themselves and their surroundings. The World Health Organisation states that art has an important role in improving health, preventing and treating diseases. Art therapy is a therapy method that includes various art branches such as music, painting, sculpture and is especially applied to individuals with oncological diseases. The place of art therapy in solving the negative biopsychosocial problems experienced by these individuals before and after surgery is increasing day by day. Although there are studies on art therapy in the literature, there is no study on art therapy after colorectal cancer surgery. Therefore, in this study, it is aimed to examine the effect of art therapy applied to patients undergoing colorectal surgery on pain, anxiety, hope and life satisfaction. The population of the study will consist of patients who underwent colorectal cancer surgery in Marmara University Pendik Training and Research Hospital General Surgery Service between December 2024 and June 2025, and the sample will consist of 96 patients who meet the research criteria and accept to participate in the study. Patients participating in the study will be divided into two equal groups as intervention and control group. In the preoperative period, the patients in the intervention and control groups will be informed about the study, written and verbal consent will be obtained from the participants who accept the study, and the patients will be asked to answer the Patient Identification Form, Herth Hope Scale and Life Satisfaction Scale. The haemodynamic parameters of the patients in the intervention group will be recorded at 14:00 on the 1st, 2nd and 3rd postoperative days, the art therapy activity they have determined will be applied for 40 minutes and the data will be obtained using the Visual Analogue Scale, State Anxiety Inventory, Herth Hope Scale and Satisfaction with Life Scale. Patients in the control group will receive only routine ward care and data will be collected on the same days and hours as the intervention group. The data obtained will be analysed with appropriate statistical methods using SPSS Windows 22.0 software. As a result of the study, it is thought that there will be an improvement in the pain, anxiety, hope and life satisfaction of the participants.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

July 10, 2025

Last Update Submit

August 16, 2025

Conditions

Keywords

surgical nursingart therapypainanxietyhopelife satisfaction

Outcome Measures

Primary Outcomes (4)

  • First evaluation- Pain

    It is a one-dimensional scale used to numerically express pain intensity. This scale consists of a 10-cm-long ruler with the words "no pain" at one end and "unbearable pain" at the other. A score of 0 cm on the scale indicates no pain, while a score of 10 cm indicates unbearable pain. As the score on the scale increases, the pain intensity increases.

    Patients' pain will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.

  • Anxiety level

    The anxiety level of the patients will be determined using the State Anxiety Inventory. The scale consists of a total of 20 items. Each item is rated on a four-point Likert-type scale: (1) not at all, (2) a little, (3) a lot, and (4) completely. The total score obtained ranges from 20 to 80. Higher scores indicate higher anxiety.

    Patients' anxiety will be assessed on postoperative days 1, 2, and 3, and on day 10 of discharge. This study is expected to last a total of 6 months, with data collection on the specified days.

  • Hope Levels

    Patients' hope levels will be assessed using the Herth Hope Scale. The scale consists of 30 items and three subscales. Each item has response options of "Not at all appropriate," "Rarely appropriate," "Sometimes appropriate," and "Always appropriate." The total score for the scale ranges from 0 to 90, with higher scores indicating higher hope.

    It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.

  • Life Satisfaction

    Patients' life satisfaction will be assessed using the Life Satisfaction Scale. The scale, consisting of five items addressing life satisfaction, has a Cronbach's alpha of 0.88. The possible score range is 5-25. A low score indicates that the individual has low life satisfaction.

    It will be evaluated one day before surgery, on the 3rd day after surgery, and on the 10th day after discharge.

Study Arms (2)

Control group

NO INTERVENTION

No application will be made to this group, and an evaluation will be made after routine nursing care.

İntervention group (Art Teraphy)

EXPERIMENTAL

Five different art therapy methods (bead jewelry making, pencil drawing, painting, mandala, clay figure making) will be applied to the people in this group.

Other: Art therapy

Interventions

Five different art therapy methods (making bead jewelry, pencil drawing, painting, mandala, making clay figures) be used for people in this group.

İntervention group (Art Teraphy)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 70,
  • Planned colorectal cancer surgery,
  • Not receiving neoadjuvant treatment (chemotherapy, radiotherapy),
  • No diagnosed psychiatric disorder,
  • No history of anxiolytic drug use,
  • Patients who volunteered to participate in the study

You may not qualify if:

  • Communication difficulties,
  • Mental deficiency,
  • Patients with dysfunction or disease in their upper extremities that may prevent them from performing art therapy practices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, 34876, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsPainAnxiety DisordersPersonal Satisfaction

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Elif Gezginci Akpinar, Assoc. Prof., PhD

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

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
Principal Investigator, PhD Student, Nurse

Study Record Dates

First Submitted

July 10, 2025

First Posted

August 22, 2025

Study Start

March 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations