Effect of Endorphin Massage on Surgical Fear, Anxiety and Pain Before Mastectomy

NCT06755983 | Not Yet Recruiting

• 1 other identifier: MERVE KAYA
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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 82 patients who underwent mastectomy surgery. This research will be conducted between January 2024 and November 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.

Conditions

Postoperative Pain; Anxiety; Fear

Keywords

mastectomy; pain; anxiety; fear; endorphin massage

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  16th 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.

  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.

  1 day before surgery]

• Surgical Fear Scale

  : 1 day before surgery\]

  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.

  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.

  On the day of surgery]

Study Arms (2)

Endhorphin massage grup

EXPERIMENTAL

The group that perform endorphin massage

Other: Endorphin massage

No interventional Grup 2

NO INTERVENTION

The group that does not perform endorphin massage

Interventions

Endorphin massage OTHER

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, 4, 8, 16, and 24, and the amount of analgesics tak

Endhorphin massage grup

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• MERVE KAYA

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MERVE KAYA KAYA

CONTACT

05313748304; merve.bagdigen@atauni.edu.tr

ZEYNEP KARAMAN ÖZLÜ

CONTACT

05434628682; zynp_krmnzl@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 1, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share