The Effect of Endorphin Massage Applied Before Mastectomy Surgery on Surgical Fear, Anxiety and Pain Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endhorphin massage grup
The group that perform endorphin massage
干预措施: Endorphin massage (Other)
No interventional Grup 2
The group that does not perform endorphin massage
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 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)
时间窗: 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.
Surgical Fear Scale
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Visual Analog Scale (VAS)
时间窗: 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
时间窗: On the day of surgery
: 1 day before surgery\]
Surgical Anxiety Scale
时间窗: 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.
Visual Analog Scale (VAS)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 16th 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
时间窗: 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 Anxiety Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
MERVE KAYA
Principal Investigator
Ataturk University