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Gynecologic CancerNCT07408349

Guided Imagery of the Gynecological Cancer

A study testing guided imagery in people with Gynecologic Cancer, run by Baskent University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized controlled trial is to evaluate the effectiveness of a guided imagery intervention in women receiving chemotherapy for gynecological cancers at Başkent University Ankara Hospital Outpatient Chemotherapy Unit. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
guided imagery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesTurkey (Türkiye)
Study dates
19 Feb 2026to 10 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having a diagnosis of another type of cancer
  • An ECOG (Eastern Cooperative Oncology Group) performance score of ≥3 (PS 3: Confined to bed for more than half of the day, limited self-care; PS 4: Completely bedridden, unable to perform self-care)

Who cannot join

  • Choosing to withdraw from the study
  • Refusing to practice guided imagery before chemotherapy treatment

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Başkent University

    Ankara, Ankara, 06790

  • Başkent University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Guided Imagery on Nausea, Vomiting, Retching, Anxiety and Quality of Life in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate the effectiveness of a guided imagery intervention in women receiving chemotherapy for gynecological cancers at Başkent University Ankara Hospital Outpatient Chemotherapy Unit.

Does guided imagery improve psychological or physical outcomes during chemotherapy? How do outcomes differ between the intervention (guided imagery) and control (standard information) groups?

Read more

Researchers will compare both groups to assess the effect of guided imagery across three repeated measurements.

Participants will:

Be randomly assigned (1:1) to intervention or control groups via an online randomization tool.

Complete outcome assessments at three time points. Be part of a minimum sample of 48 women (24 participants per group), based on the power analysis.

The study will follow the CONSORT-Outcomes 2022 guideline and be registered at ClinicalTrials.gov.

Read the detailed description

Gynecological cancers are among the most common cancers in women after breast cancer. According to GLOBOCAN (2022), 1.3 million new gynecological cancer cases were reported worldwide. In Turkey, the incidence of female reproductive organ cancers is 23.8%, with endometrial, ovarian, and cervical cancers being the most common.

Treatment methods include surgery, chemotherapy, and radiotherapy, with platinum-based chemotherapy regimens widely preferred. However, chemotherapy causes numerous side effects such as nausea-vomiting, fatigue, anxiety, depression, and decreased quality of life. Complementary and alternative medicine approaches have been reported as effective in managing these symptoms.

One mind-body based complementary method, guided imagery, aims to help individuals achieve relaxation, cope with stress, and experience physical comfort through mental imagery. Developed by Lerner, this technique uses themes such as "meadow, mountain, stream, home, and close relative." Guided imagery has shown positive effects like reducing stress, enhancing immunity, alleviating nausea-vomiting, and improving quality of life.

Studies have demonstrated that guided imagery is effective in symptom management and improving psychological well-being especially in breast and gynecological cancer patients. However, research investigating the effect of this technique during chemotherapy in gynecological cancer patients is limited.

This study is designed to evaluate the effects of guided imagery on nausea, vomiting, recthing, anxiety, and quality of life in women undergoing chemotherapy for gynecological cancers.

Being tested
guided imagery
Keywords
gynecologic cancer, guided imagery, nausea, vomiting, retching, anxiety, quality of life, nursing
Medical subject headings
Nausea, Vomiting, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • guided imageryBehavioural

    Guided imagery is a method of mind-body communication, fundamentally defined as a flow of thoughts involving what we smell, taste, see, hear, and touch, or as the way our mind encodes, stores, and retrieves information. It is based on the understanding that the body and mind are interconnected and that the mind can influence the body. Stress and anxiety directly affect the brain and immune system

Study groups in NCT07408349
Study groupRoleWhat they receive
InterventionExperimentalIn the first phase, all participants will complete a Sociodemographic Data Form. The State-Trait Anxiety Inventory and FACT-G will be applied as pre- and post-tests during each of the three chemotherapy sessions. The MASCC Antiemesis Tool will be administered after the 1st session and before/after the 2nd and 3rd sessions. Participants will also self-complete the MASCC scale and a nausea-vomiting diary for seven days after each cycle. On day 7, the FACT-G will be administered via phone to evaluate changes in functional and emotional status.
Receives: Behavioral: guided imagery
controlNo interventionIn each chemotherapy cycle (1st, 2nd, and 3rd), control group patients will complete the Sociodemographic Form and State-Trait Anxiety Inventory before treatment, and State-Trait Anxiety Inventory again post-treatment. They will receive the MASCC Antiemesis Scale and a nausea/vomiting diary to complete daily for 7 days. On day 7, the FACT-G and a telephone follow-up form will be administered via phone. This standardized procedure will be repeated in all three cycles to ensure consistent data collection.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Functional Assessment of Cancer Therapy - General (FACT-G)

    The Functional Assessment of Cancer Therapy-General (FACT-G) is part of the FACIT system developed to assess health-related quality of life in individuals with cancer. Due to its cancer-specific structure, FACT-G was used in this study. FACT-G Version 4 includes 27 items across four domains: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). Domain scores are calculated according to FACIT guidelines with adjustment for missing data. Score ranges are 0-28 for Physical, Social/Family, and Functional domains, and 0-24 for Emotional Well-Being. The total FACT-G score ranges from 0 to 108, with higher scores indicating better quality of life.

    Measured: through study completion, an average of 1 year

  2. The State-Trait Anxiety Inventory (STAI)

    developed by Spielberger et al. (1983), assesses state and trait anxiety in individuals with or without pathology. Its Turkish validity was established by Öner and Le Compte (1983). In this study, STAI Form I was used to measure chemotherapy-related state anxiety. The inventory includes two separate 20-item scales and can be self- or interviewer-administered to individuals aged 14 and older. Responses are rated on a 4-point Likert scale. The scales include direct and reverse-coded items; reverse items are recoded before scoring. Total scores range from 20 to 80, with higher scores indicating higher anxiety levels.

    Measured: through study completion, an average of 1 year

  3. nausea, vomiting, retching

    nausea, vomiting, retching numbers

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start19 Feb 2026
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
RANDOMİZED CONTROL TRİAL
Masking
Single blind
Who is masked
Participant
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408349
Sponsor's protocol ID
KYURDAKULL
Status last verified
Oct 2026
First submitted
19 Nov 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Acar K, Ersoz H. Effect of Guided Imagery on Patient Comfort, Vital Signs, Pain, Anxiety, and Satisfaction in Cancer Patients Undergoing Port Catheterization With Local Anesthesia: A Prospective Randomized Controlled Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):93-99. doi: 10.1097/NCC.0000000000001194. Epub 2023 Oct 28.

    PubMed 37903178

  • Afshar, M., Mohsenzadeh, A., ve Sarafrazi, N. (2020). The effect of guided imagery on anxiety and sleep quality in hemodialysis patients: A randomized clinical trial. Qom University of Medical Sciences Journal, 13(11), 59-67.

  • Ay, S., Parvizi, M. (2021). The Functional Assessment of Cancer Therapy General (FACT-G) Scale: Reliability and validity of Turkish version. Manisa Celal Bayar Ünivercity Journal of Institute of Health Science, 8(2), 198-203. doi:1034087/cbusbed.692556

  • Chirico A, Maiorano P, Indovina P, Milanese C, Giordano GG, Alivernini F, Iodice G, Gallo L, De Pietro G, Lucidi F, Botti G, De Laurentiis M, Giordano A. Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. J Cell Physiol. 2020 Jun;235(6):5353-5362. doi: 10.1002/jcp.29422. Epub 2020 Jan 20.

    PubMed 31957873

Questions about this trial

What is this clinical trial studying?

A study testing guided imagery in people with Gynecologic Cancer, run by Baskent University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Functional Assessment of Cancer Therapy - General (FACT-G) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408349, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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