Postoperative PainMastectomyNCT06755983
Effect of Endorphin Massage on Surgical Fear, Anxiety and Pain Before Mastectomy
A study testing Endorphin massage in people with Postoperative Pain and Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This research is planned to investigate the effect of endorphin massage applied before mastectomy surgery on surgical anxiety and fear and pain. This was a randomized, controlled experimental study. The sample comprised 61 patients who underwent mastectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Anxiety, Fear
- What is being tested?
- Endorphin massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Sep 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and above
- Those who are aware of their diagnosis
- Receiving 4-6 cycles of neoadjuvant treatment on a monthly basis
- Scheduled for their first mastectomy surgery
- Those whose cognitive level is suitable for applying the scales
Who cannot join
- Patients with metastasis
- Patients with a diagnosed severe mental disorder
- Patients enrolled in a different study conducted in the clinic
- Patients who cannot comply with the study process and conditions
- Patients who withdraw from the study at their own request
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University- Faculty of Nursing
Erzurum, Yakutiye, 25000
About this study
Official title: The Effect of Endorphin Massage Applied Before Mastectomy Surgery on Surgical Fear, Anxiety and Pain Levels
This research is planned to investigate the effect of endorphin massage applied before mastectomy surgery on surgical anxiety and fear and pain. This was a randomized, controlled experimental study. The sample comprised 61 patients who underwent mastectomy surgery. This research will be conducted between January 2025-September 2025 at the Atatürk University Health Practice and Research Hospital, Breast-Endocrine Clinic.The data will be collected using the Introductory Information Form, Surgical Anxiety Scale, Surgical Fear Scale, and Visual Analog Scale.
Read the detailed description
This research is planned to investigate the effect of endorphin massage applied before mastectomy surgery on surgical anxiety and fear and pain. This was a randomized, controlled experimental study. The sample comprised 61 patients who underwent mastectomy surgery. This research will be conducted between January 2025-September 2025 at the Atatürk University Health Practice and Research Hospital, Breast-Endocrine Clinic.The data will be collected using the Introductory Information Form, Surgical Anxiety Scale, Surgical Fear Scale, and Visual Analog Scale.
Data Collection The research will be conducted after obtaining institutional permission and ethical committee approval. Following the necessary information provided to the healthcare professionals in the clinic where the study will be conducted, collaboration will be established to carry out the study. Patients who meet the inclusion criteria will be invited to participate after being interviewed one day before the surgery. Verbal and written consent will be obtained from the patients who volunteer and agree to participate in the study. The patients will be divided into two groups according to the randomization list, and all groups will be informed about how to fill out the follow-up forms. In the General Surgery Clinic, mastectomy surgery is scheduled to be performed. Patients are admitted to the clinic one day before the surgery, and if no complications arise, they are discharged on the third day. Postoperative pain management in both the experimental and control groups was conducted according to the same institutional analgesia protocol prescribed by the attending surgeons. Pain severity was assessed using the Visual Analog Scale (VAS), and analgesics were administered by ward nurses in accordance with physician orders. Intravenous paracetamol (1 g/100 mL) was administered for mild to moderate pain, while intravenous dexketoprofen trometamol (50 mg/2 mL) was administered for moderate to severe pain in cases deemed clinically necessary by the attending physician. The same analgesia protocol was applied to both groups throughout the study. Non-pharmacological interventions for anxiety relief, including pre- and post-surgery education and patient training, will be routinely provided.
Patients in both the experimental and control groups who are admitted to the clinic will be informed about the study, and the researcher will introduce themselves. Patients in the experimental group will be taken to a suitable room for the endorphin massage, where the massage will be applied. During this time, routine preoperative care will be performed by nurses. For Group 1 (experimental group), patients admitted to the clinic one day before surgery will complete the first two sections of the Patient Diagnosis Form (I. Individual characteristics and II. Health and illness-related data), the Surgical Fear and Anxiety Scale, and the VAS scales will be applied after the endorphin massage. The endorphin massage, which will last approximately 20 minutes, will be explained to the patients. The application is in accordance with evidence-based guidelines, which state that the intensity of the patient's pain should be assessed before the surgery for postoperative pain management planning and goals. Therefore, pain scores will be recorded preoperatively using the VAS scale. On the morning of the surgery, before going to the operating room, the endorphin massage will be repeated, and the scales will be applied again. After the surgery, patients will have their pain levels measured using the VAS at hours 0, 2, 4, 8, 12, and 24, and the amount of analgesics taken during the first 24 hours will be recorded.
For Group 2 (control group), no intervention will be applied, and routine preoperative care will be provided by nurses. Before the surgery, without the endorphin massage, the first two sections of the Patient Diagnosis Form, the Surgical Fear and Anxiety Scale, and the VAS scales will be applied to the patients. On the morning of the surgery, the scales will be applied again without any intervention. After surgery, patients will have their pain levels measured using the VAS at hours 0, 2, 4, 8, 12, and 24, and the amount of analgesics taken during the first 24 hours will be recorded.
Key points for Endorphin Massage Application:
The room temperature for the massage should be set between 21-24°C. The massage room should be quiet, with adjustments made to reduce television and monitor sounds, and phones set to silent mode.
The room should be adequately lit. The massage should be given in a position that ensures the patient's comfort.
Randomization:
Due to the nature of the study, the researcher will be involved in the endorphin massage application, data collection, and input stages. Additionally, the women in the intervention group must be informed about the study. Therefore, blinding of the researcher and participants is not possible. However, randomization will be implemented to prevent selection bias. Patients undergoing mastectomy will be screened according to inclusion and exclusion criteria, and eligible participants will be invited to the study. After obtaining written informed consent from those who agree to participate, block randomization will be used to assign participants to two groups. The randomization list will be generated using a computer-based random number table from (https://www.randomizer.org), and participants will be assigned to one of the two groups based on the order of inclusion. Group 1 will consist of patients who receive the endorphin massage, while Group 2 will consist of patients with no intervention.
Data Evaluation Statistical evaluation will be performed using a blinding method. Data analysis will be conducted by a statistician. After ensuring the data is coded and labeled to maintain blinding, the data will be sent to the statistician for analysis. The data will be analyzed using SPSS for Windows 22 software. A statistical significance level of 0.05 will be used, with a Type I error rate of 5% and a 95% confidence interval. Normality distribution of the data will be assessed using Kurtosis and Skewness values (±2). Descriptive statistics such as numbers, percentages, means, and standard deviations will be calculated. For comparisons of the two groups, independent samples t-test will be used for normally distributed measurements, and Mann-Whitney U test will be used for non-normally distributed measurements. For within-group comparisons, dependent samples t-test will be used for normally distributed measurements, and Wilcoxon test will be used for non-normally distributed measurements.
Ethical Principles of the Research
The study will begin after obtaining approval from the Atatürk University Faculty of Medicine Ethics Committee and written permission from the center where the research will be conducted. During data collection, patients will be informed about the study, and the ethical principles of "Informed Consent," "Respect for Autonomy," and "Confidentiality and Protection of Privacy" will be followed. Since individual rights must be protected in the study, the research will adhere to the Helsinki Declaration of Human Rights throughout the study period. Patients who are willing to participate and meet the inclusion criteria will be included in the study. Verbal and written consent will be obtained from the patients before data collection.
Limitations and Generalizability of the Research The study will be limited to patients who are admitted to the Breast-Endocrine Clinic of the Atatürk University Health Practice and Research Hospital, meet the sample selection criteria, and agree to participate. Therefore, the results of the study can only be generalized to patients with characteristics similar to those in this sample group.
- Conditions
- Postoperative Pain, Anxiety, Fear
- Being tested
- Endorphin massage
- Keywords
- mastectomy, pain, anxiety, fear, endorphin massage
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorphin massageOther
For Group 1 (experimental group), patients admitted to the clinic one day before surgery will complete the first two sections of the Patient Diagnosis Form (I. Individual characteristics and II. Health and illness-related data), the Surgical Fear and Anxiety Scale, and the VAS scales after the endorphin massage. The patients will be informed that the endorphin massage will last approximately 20 minutes. According to evidence-based current guidelines, it is stated that the intensity of the patient's pain should be assessed during the preoperative period for pain management planning and goals in the postoperative period. Therefore, patients' pain scores will also be recorded preoperatively using the VAS scale. On the morning of the surgery, before going to the operating room, the endorphin massage will be repeated, and the scales will be applied again. After surgery, patients will have their pain levels measured using the VAS at hours 0,2, 4,8,12and 24, and the amount of analgesics tak
| Study group | Role | What they receive |
|---|---|---|
| Endhorphin massage grup | Experimental | The group that perform endorphin massage Receives: Other: Endorphin massage |
| No interventional Grup 2 | No intervention | The group that does not perform endorphin massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 0th hour
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 2th hour
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 4th hour
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 8th hour
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 12th hour
Visual Analog Scale (VAS)
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Measured: 24th hour
Surgical Fear Scale
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Measured: 1 day before surgery]
Surgical Fear Scale
: 1 day before surgery]
Measured: On the day of surgery
Surgical Fear Scale
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Measured: morning before surgery (before massage)
Surgical Fear Scale
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Measured: morning before surgery (after massage)
Surgical Anxiety Scale
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Measured: 1 day before surgery
Surgical Anxiety Scale
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Measured: On the day of surgery]
Surgical Anxiety Scale
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Measured: morning before surgery (before massage)
Surgical Anxiety Scale
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Measured: morning before surgery (after massage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KAYA, Ataturk University
- Investigators
- MERVE KAYA, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755983
- Sponsor's protocol ID
- MERVE KAYA
- Acronym
- Mastectomy
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endorphin Massage Applied Before Mastectomy Surgery on Surgical Fear, Anxiety and Pain Levels
- ClinicalTrials.gov ID
- NCT06755983
- Acronym / sponsor ID
- Mastectomy / MERVE KAYA
- Conditions
- Postoperative Pain, Anxiety, Fear
- Keywords
- mastectomy, pain, anxiety, fear, endorphin massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 1 Jan 2025 (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 research is planned to investigate the effect of endorphin massage applied before mastectomy surgery on surgical anxiety and fear and pain. This was a randomized, controlled experimental study. The sample comprised 61 patients who underwent mastectomy surgery. This research will be conducted between January 2025-September 2025 at the Atatürk University Health Practice and Research Hospital, Breast-Endocrine Clinic.The data will be collected using the Introductory Information Form, Surgical Anxiety Scale, Surgical Fear Scale, and Visual Analog Scale.
Detailed description
This research is planned to investigate the effect of endorphin massage applied before mastectomy surgery on surgical anxiety and fear and pain. This was a randomized, controlled experimental study. The sample comprised 61 patients who underwent mastectomy surgery. This research will be conducted between January 2025-September 2025 at the Atatürk University Health Practice and Research Hospital, Breast-Endocrine Clinic.The data will be collected using the Introductory Information Form, Surgical Anxiety Scale, Surgical Fear Scale, and Visual Analog Scale.
Data Collection The research will be conducted after obtaining institutional permission and ethical committee approval. Following the necessary information provided to the healthcare professionals in the clinic where the study will be conducted, collaboration will be established to carry out the study. Patients who meet the inclusion criteria will be invited to participate after being interviewed one day before the surgery. Verbal and written consent will be obtained from the patients who volunteer and agree to participate in the study. The patients will be divided into two groups according to the randomization list, and all groups will be informed about how to fill out the follow-up forms. In the General Surgery Clinic, mastectomy surgery is scheduled to be performed. Patients are admitted to the clinic one day before the surgery, and if no complications arise, they are discharged on the third day. Postoperative pain management in both the experimental and control groups was conducted according to the same institutional analgesia protocol prescribed by the attending surgeons. Pain severity was assessed using the Visual Analog Scale (VAS), and analgesics were administered by ward nurses in accordance with physician orders. Intravenous paracetamol (1 g/100 mL) was administered for mild to moderate pain, while intravenous dexketoprofen trometamol (50 mg/2 mL) was administered for moderate to severe pain in cases deemed clinically necessary by the attending physician. The same analgesia protocol was applied to both groups throughout the study. Non-pharmacological interventions for anxiety relief, including pre- and post-surgery education and patient training, will be routinely provided.
Patients in both the experimental and control groups who are admitted to the clinic will be informed about the study, and the researcher will introduce themselves. Patients in the experimental group will be taken to a suitable room for the endorphin massage, where the massage will be applied. During this time, routine preoperative care will be performed by nurses. For Group 1 (experimental group), patients admitted to the clinic one day before surgery will complete the first two sections of the Patient Diagnosis Form (I. Individual characteristics and II. Health and illness-related data), the Surgical Fear and Anxiety Scale, and the VAS scales will be applied after the endorphin massage. The endorphin massage, which will last approximately 20 minutes, will be explained to the patients. The application is in accordance with evidence-based guidelines, which state that the intensity of the patient's pain should be assessed before the surgery for postoperative pain management planning and goals. Therefore, pain scores will be recorded preoperatively using the VAS scale. On the morning of the surgery, before going to the operating room, the endorphin massage will be repeated, and the scales will be applied again. After the surgery, patients will have their pain levels measured using the VAS at hours 0, 2, 4, 8, 12, and 24, and the amount of analgesics taken during the first 24 hours will be recorded.
For Group 2 (control group), no intervention will be applied, and routine preoperative care will be provided by nurses. Before the surgery, without the endorphin massage, the first two sections of the Patient Diagnosis Form, the Surgical Fear and Anxiety Scale, and the VAS scales will be applied to the patients. On the morning of the surgery, the scales will be applied again without any intervention. After surgery, patients will have their pain levels measured using the VAS at hours 0, 2, 4, 8, 12, and 24, and the amount of analgesics taken during the first 24 hours will be recorded.
Key points for Endorphin Massage Application:
The room temperature for the massage should be set between 21-24°C. The massage room should be quiet, with adjustments made to reduce television and monitor sounds, and phones set to silent mode.
The room should be adequately lit. The massage should be given in a position that ensures the patient's comfort.
Randomization:
Due to the nature of the study, the researcher will be involved in the endorphin massage application, data collection, and input stages. Additionally, the women in the intervention group must be informed about the study. Therefore, blinding of the researcher and participants is not possible. However, randomization will be implemented to prevent selection bias. Patients undergoing mastectomy will be screened according to inclusion and exclusion criteria, and eligible participants will be invited to the study. After obtaining written informed consent from those who agree to participate, block randomization will be used to assign participants to two groups. The randomization list will be generated using a computer-based random number table from (https://www.randomizer.org), and participants will be assigned to one of the two groups based on the order of inclusion. Group 1 will consist of patients who receive the endorphin massage, while Group 2 will consist of patients with no intervention.
Data Evaluation Statistical evaluation will be performed using a blinding method. Data analysis will be conducted by a statistician. After ensuring the data is coded and labeled to maintain blinding, the data will be sent to the statistician for analysis. The data will be analyzed using SPSS for Windows 22 software. A statistical significance level of 0.05 will be used, with a Type I error rate of 5% and a 95% confidence interval. Normality distribution of the data will be assessed using Kurtosis and Skewness values (±2). Descriptive statistics such as numbers, percentages, means, and standard deviations will be calculated. For comparisons of the two groups, independent samples t-test will be used for normally distributed measurements, and Mann-Whitney U test will be used for non-normally distributed measurements. For within-group comparisons, dependent samples t-test will be used for normally distributed measurements, and Wilcoxon test will be used for non-normally distributed measurements.
Ethical Principles of the Research
The study will begin after obtaining approval from the Atatürk University Faculty of Medicine Ethics Committee and written permission from the center where the research will be conducted. During data collection, patients will be informed about the study, and the ethical principles of "Informed Consent," "Respect for Autonomy," and "Confidentiality and Protection of Privacy" will be followed. Since individual rights must be protected in the study, the research will adhere to the Helsinki Declaration of Human Rights throughout the study period. Patients who are willing to participate and meet the inclusion criteria will be included in the study. Verbal and written consent will be obtained from the patients before data collection.
Limitations and Generalizability of the Research The study will be limited to patients who are admitted to the Breast-Endocrine Clinic of the Atatürk University Health Practice and Research Hospital, meet the sample selection criteria, and agree to participate. Therefore, the results of the study can only be generalized to patients with characteristics similar to those in this sample group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Endhorphin massage grup | Experimental | Other: Endorphin massageThe group that perform endorphin massage |
| No interventional Grup 2 | No intervention | –The group that does not perform endorphin massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 and above
- Those who are aware of their diagnosis
- Receiving 4-6 cycles of neoadjuvant treatment on a monthly basis
- Scheduled for their first mastectomy surgery
- Those whose cognitive level is suitable for applying the scales
Key exclusion criteria (5 listed)
- Patients with metastasis
- Patients with a diagnosed severe mental disorder
- Patients enrolled in a different study conducted in the clinic
- Patients who cannot comply with the study process and conditions
- Patients who withdraw from the study at their own request
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 |
|---|---|---|
| Endorphin massageFor Group 1 (experimental group), patients admitted to the clinic one day before surgery will complete the first two sections of the Patient Diagnosis Form (I. Individual characteristics and II. Health and illness-related data), the Surgical Fear and Anxiety Scale, and the VAS scales after the endorphin massage. The patients will be informed that the endorphin massage will last approximately 20 minutes. According to evidence-based current guidelines, it is stated that the intensity of the patient's pain should be assessed during the preoperative period for pain management planning and goals in the postoperative period. Therefore, patients' pain scores will also be recorded preoperatively using the VAS scale. On the morning of the surgery, before going to the operating room, the endorphin massage will be repeated, and the scales will be applied again. After surgery, patients will have their pain levels measured using the VAS at hours 0,2, 4,8,12and 24, and the amount of analgesics tak | Other | Endhorphin massage grup |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 0th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Visual Analog Scale (VAS)
Time frame: 2th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Visual Analog Scale (VAS)
Time frame: 4th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Visual Analog Scale (VAS)
Time frame: 8th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Visual Analog Scale (VAS)
Time frame: 12th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Visual Analog Scale (VAS)
Time frame: 24th hour
For pain assessment, the patient is asked to indicate the perceived intensity of pain along a 100 mm horizontal line, and this rating is measured starting from the left side. Patients are asked to score their pain level on a scale from 0 to 10 on the horizontal line. 0 represents no pain, and 10 represents unbearable pain. Due to its simplicity, validity, and reliability, this scale is considered the most appropriate tool for describing pain intensity.
Surgical Fear Scale
Time frame: 1 day before surgery]
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Surgical Fear Scale
Time frame: On the day of surgery
: 1 day before surgery]
Surgical Fear Scale
Time frame: morning before surgery (before massage)
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Surgical Fear Scale
Time frame: morning before surgery (after massage)
The scale consists of 8 items on a 0-10 numerical scale. This scale, which has two subdimensions, measures the fear related to the short-term and long-term outcomes of the surgical intervention. Items 1-4 assess the fear of the short-term outcomes of the surgery, while items 5-8 measure the fear of the long-term outcomes of the surgery. An increase in the scale score indicates that the fear of surgery is high.
Surgical Anxiety Scale
Time frame: 1 day before surgery
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Surgical Anxiety Scale
Time frame: On the day of surgery]
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Surgical Anxiety Scale
Time frame: morning before surgery (before massage)
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Surgical Anxiety Scale
Time frame: morning before surgery (after massage)
The scale has three subdimensions: Health-Related Anxiety (items 7, 8, 9, 10, 12, and 13), Recovery-Related Anxiety (items 2, 14, 16, and 17), and Procedure-Related Anxiety (items 1, 3, 4, and 5). The total score of the Surgical Anxiety Scale (SAS) is obtained by summing the scores of the subdimension items and the three items not included in any subdimension. The lowest possible score on the scale is 0, and the highest score is 68. As the score increases, the level of surgical anxiety is considered higher.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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.
MERVE KAYA principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endorphin massage in people with Postoperative Pain and Anxiety, run by Ataturk 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 5 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: finished, as of the sponsor's last update on 24 Sep 2026. 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?
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?
Visual Analog Scale (VAS) (time frame: 0th hour). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.