BrachytherapyNCT06531551
The Effect of Acupressure on Patients Receiving Brachytherapy
A study testing The group to which Acupressure will be applied in each fraction in people with Brachytherapy and Complementary Approaches, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to use acupressure to reduce anxiety in gynecologic cancer patients receiving brachytherapy. It was also aimed to investigate the effects of acupressure on anxiety, pain, and vital signs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brachytherapy, Complementary Approaches, Gynecological Cancers
- What is being tested?
- The group to which Acupressure will be applied in each fraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2024to 10 Oct 2024
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being registered in Selçuk University Faculty of Medicine Hospital Radiation Oncology Polyclinic
- Brachytherapy (intracavital brachytherapy) treatment protocol will be applied due to gynecological cancer.
- to be
- Karnofsky Performance Scale being 80 and above (Performance scale for cancer patients)
- Being between the ages of 18 and 65
- Being conscious and cooperative
- Verbal and written approval to participate in the study after an explanation about the study is made.
Who cannot join
- Impaired skin integrity in the acupressure application area
- Refuses to participate in the study after making a statement about the study.
- Bone or spine metastasis
- Amputation of the extremities to be applied
- Not having any mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Effect of Acupressure on Anxiety, Pain and Vital Signs in Gynecological Cancer Patients Receiving Brachytherapy: A Randomized Controlled Study"
This study aimed to use acupressure to reduce anxiety in gynecologic cancer patients receiving brachytherapy. It was also aimed to investigate the effects of acupressure on anxiety, pain, and vital signs.
Read the detailed description
Brachytherapy is a type of radiotherapy used in cancer treatment. In this method, the radiation source is placed directly on the tumor or the area to be treated. In this way, high doses of radiation are applied only to the target area, while surrounding healthy tissues are less damaged. Brachytherapy is usually used in the treatment of certain types of cancer, such as prostate, cervix, breast, and skin cancer. Gynecological brachytherapy is the application of brachytherapy in the treatment of gynecological cancers. It can be used especially in cancers of the uterus, cervix, vagina, and vulva. This treatment method is performed by placing the radiation source in the area where the tumor is located. Brachytherapy can be used in combination with surgery, chemotherapy, or other types of radiotherapy in the treatment of these types of cancers. Factors such as cancer burden, the problem of achieving remission, and the need for patients to remain immobile during the procedure, which is performed in a room that needs to be isolated due to radiation, contribute to symptoms such as pain and anxiety before and during treatment. These symptoms can sometimes affect vital signs. The need for patients to remain immobile during brachytherapy, the need to be isolated in a room due to radiation, and the discomfort caused by the applicators also increase anxiety in women. Patients often experience fear and anxiety because there is insufficient information about brachytherapy that could help relieve their pain and anxiety. Despite the complexity of such a procedure and the significant patient population, there are few studies on women's experiences with brachytherapy.
- Being tested
- The group to which Acupressure will be applied in each fraction
- Keywords
- Brachytherapy, Acupressure, Nursing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group to which Acupressure will be applied in each fractionOther
Acupressure application protocol will be started after patient information. This process is planned to take 30 minutes.Before the application, approximately 20 seconds of warming and rubbing without direct pressure on the acupressure points will be performed to reduce tissue sensitivity and prepare the points for acupressure. Subsequently, the researcher will apply pressure with the thumb on the predetermined acupressure points, considering the individual's pain threshold, with 10 seconds of pressure followed by two seconds of relaxation without lifting the finger, in consecutive presses following the rhythm of breathing. A digital clock (belonging to the researcher) will be used to determine the duration of the acupressure application.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Acupressure Receives: Other: The group to which Acupressure will be applied in each fraction |
| Control | No intervention | Only routine practices of the clinic will be carried out |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory
The Turkish validity and reliability of the State Anxiety Scale developed by Spielberger and his team in 1970 were conducted by Öner and Le Compte (1983). This scale is used to evaluate the emotional state that an individual feels at a specific moment and under specific conditions. The scale consists of 20 items and is evaluated on a four-point Likert scale (1-not at all, 2-somewhat, 3-very much, 4-completely). The scale includes both direct statements (3, 4, 6, 7, 9, 12, 13, 14, 17, 18) and reversed statements (1, 2, 5, 8, 10, 11, 15, 16, 19, 20).In direct statements, a value of 4 indicates high anxiety, while in reverse statements, a value of 1 signifies high anxiety. The total score range is 20-80, and this scoring is interpreted as follows: "no anxiety" between 0-19, "mild anxiety" between 20-39, "moderate anxiety" between 40-59, "severe anxiety" between 60-79, and a score of 80 is considered a "panic value.
Measured: day 1
Visual Analog Scale
On a 10 cm ruler with "no pain" marked at one end and "worst pain imaginable" at the other, the patient indicates their perceived level of pain. The Visual Analog Scale (VAS) is reported to be more sensitive and reliable in assessing pain intensity compared to other single-dimensional scales in the measurement of pain severity according to the Numeric Rating Scale.
Measured: day 1
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith in 1983 (Zigmond AS \& Snaith RP, 1983). It is stated that the scale is a reliable tool for detecting depression and anxiety in outpatient settings and provides valid measurements of the severity of emotional disorders through depression and anxiety subscales. In the scale consisting of 14 items, odd-numbered items investigate the anxiety sub-dimension, even-numbered items investigate the depression sub-dimension. It has a four-point Liket type feature between 0 and 3 points. Scoring for odd-numbered items 1, 3, 5, 6, 8, 10, 11 and 13 is 3, 2, 1, 0. Even items 2, 4, 7, 9, 12 and 14 are scored as 0,1,2,3. The scale score range is between 0-42. The cut-off score for the anxiety subscale was reported as 10, and the cut-off score for the depression subscale was reported as 7. Individuals who score above these scores constitute the risk group.
Measured: day 1
Vital signs
Body temperature, Blood pressure, Pulse, Respiration; will be manually assessed by the researcher for 1 minute. Record will be made on the Personal Information Form.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start28 Aug 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BrachytherapyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Saygılı, Selcuk University
- Investigators
- ülkü Saygili Düzova, Study director, Selçuk Üniversitesi Hemşirelik Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531551
- Sponsor's protocol ID
- 18.04.24
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duzova US, Can G, Duzova M, Basaran H, Yavas C. The effect of acupressure on anxiety, depression, pain, and vital signs in gynecological cancer patients receiving brachytherapy: A randomized controlled study. Support Care Cancer. 2025 Jul 18;33(8):698. doi: 10.1007/s00520-025-09754-6.
PubMed 40679634
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Acupressure on Anxiety, Pain and Vital Signs in Gynecological Cancer Patients Receiving Brachytherapy: A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT06531551
- Acronym / sponsor ID
- 18.04.24
- Keywords
- Brachytherapy, Acupressure, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to use acupressure to reduce anxiety in gynecologic cancer patients receiving brachytherapy. It was also aimed to investigate the effects of acupressure on anxiety, pain, and vital signs.
Detailed description
Brachytherapy is a type of radiotherapy used in cancer treatment. In this method, the radiation source is placed directly on the tumor or the area to be treated. In this way, high doses of radiation are applied only to the target area, while surrounding healthy tissues are less damaged. Brachytherapy is usually used in the treatment of certain types of cancer, such as prostate, cervix, breast, and skin cancer. Gynecological brachytherapy is the application of brachytherapy in the treatment of gynecological cancers. It can be used especially in cancers of the uterus, cervix, vagina, and vulva. This treatment method is performed by placing the radiation source in the area where the tumor is located. Brachytherapy can be used in combination with surgery, chemotherapy, or other types of radiotherapy in the treatment of these types of cancers. Factors such as cancer burden, the problem of achieving remission, and the need for patients to remain immobile during the procedure, which is performed in a room that needs to be isolated due to radiation, contribute to symptoms such as pain and anxiety before and during treatment. These symptoms can sometimes affect vital signs. The need for patients to remain immobile during brachytherapy, the need to be isolated in a room due to radiation, and the discomfort caused by the applicators also increase anxiety in women. Patients often experience fear and anxiety because there is insufficient information about brachytherapy that could help relieve their pain and anxiety. Despite the complexity of such a procedure and the significant patient population, there are few studies on women's experiences with brachytherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: The group to which Acupressure will be applied in each fractionAcupressure |
| Control | No intervention | –Only routine practices of the clinic will be carried out |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being registered in Selçuk University Faculty of Medicine Hospital Radiation Oncology Polyclinic
- Brachytherapy (intracavital brachytherapy) treatment protocol will be applied due to gynecological cancer.
- to be
- Karnofsky Performance Scale being 80 and above (Performance scale for cancer patients)
- Being between the ages of 18 and 65
Key exclusion criteria (5 listed)
- Impaired skin integrity in the acupressure application area
- Refuses to participate in the study after making a statement about the study.
- Bone or spine metastasis
- Amputation of the extremities to be applied
- Not having any mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The group to which Acupressure will be applied in each fractionAcupressure application protocol will be started after patient information. This process is planned to take 30 minutes.Before the application, approximately 20 seconds of warming and rubbing without direct pressure on the acupressure points will be performed to reduce tissue sensitivity and prepare the points for acupressure. Subsequently, the researcher will apply pressure with the thumb on the predetermined acupressure points, considering the individual's pain threshold, with 10 seconds of pressure followed by two seconds of relaxation without lifting the finger, in consecutive presses following the rhythm of breathing. A digital clock (belonging to the researcher) will be used to determine the duration of the acupressure application. | Other | Study |
Primary outcome
The State-Trait Anxiety Inventory
Time frame: day 1
The Turkish validity and reliability of the State Anxiety Scale developed by Spielberger and his team in 1970 were conducted by Öner and Le Compte (1983). This scale is used to evaluate the emotional state that an individual feels at a specific moment and under specific conditions. The scale consists of 20 items and is evaluated on a four-point Likert scale (1-not at all, 2-somewhat, 3-very much, 4-completely). The scale includes both direct statements (3, 4, 6, 7, 9, 12, 13, 14, 17, 18) and reversed statements (1, 2, 5, 8, 10, 11, 15, 16, 19, 20).In direct statements, a value of 4 indicates high anxiety, while in reverse statements, a value of 1 signifies high anxiety. The total score range is 20-80, and this scoring is interpreted as follows: "no anxiety" between 0-19, "mild anxiety" between 20-39, "moderate anxiety" between 40-59, "severe anxiety" between 60-79, and a score of 80 is considered a "panic value.
Visual Analog Scale
Time frame: day 1
On a 10 cm ruler with "no pain" marked at one end and "worst pain imaginable" at the other, the patient indicates their perceived level of pain. The Visual Analog Scale (VAS) is reported to be more sensitive and reliable in assessing pain intensity compared to other single-dimensional scales in the measurement of pain severity according to the Numeric Rating Scale.
The Hospital Anxiety and Depression Scale
Time frame: day 1
The Hospital Anxiety and Depression Scale was developed by Zigmond and Snaith in 1983 (Zigmond AS \& Snaith RP, 1983). It is stated that the scale is a reliable tool for detecting depression and anxiety in outpatient settings and provides valid measurements of the severity of emotional disorders through depression and anxiety subscales. In the scale consisting of 14 items, odd-numbered items investigate the anxiety sub-dimension, even-numbered items investigate the depression sub-dimension. It has a four-point Liket type feature between 0 and 3 points. Scoring for odd-numbered items 1, 3, 5, 6, 8, 10, 11 and 13 is 3, 2, 1, 0. Even items 2, 4, 7, 9, 12 and 14 are scored as 0,1,2,3. The scale score range is between 0-42. The cut-off score for the anxiety subscale was reported as 10, and the cut-off score for the depression subscale was reported as 7. Individuals who score above these scores constitute the risk group.
Vital signs
Time frame: day 1
Body temperature, Blood pressure, Pulse, Respiration; will be manually assessed by the researcher for 1 minute. Record will be made on the Personal Information Form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40679634Duzova US, Can G, Duzova M, Basaran H, Yavas C. The effect of acupressure on anxiety, depression, pain, and vital signs in gynecological cancer patients receiving brachytherapy: A randomized controlled study. Support Care Cancer. 2025 Jul 18;33(8):698. doi: 10.1007/s00520-025-09754-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ülkü Saygili Düzova study director
Selçuk Üniversitesi Hemşirelik Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group to which Acupressure will be applied in each fraction in people with Brachytherapy and Complementary Approaches, run by Selcuk University at 1 site 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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 State-Trait Anxiety Inventory (time frame: day 1). The study lists 4 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 NCT06531551, which also lists 1 linked publication.
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 1 Aug 2024.