The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing

NCT04680754 | Completed DMC

• 1 other identifier: 2018/1763
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Thyroid diseases are one of the most common health problems all over the world. After thyroidectomy, patients often experience discomfort such as neck pain, shoulder stiffness, shoulder movement difficulty, choking or pressing feeling. Head-neck stretching exercises provide neuromuscular coordination and flexibility in patients by reducing pain and muscle weakness. Methods: This research was carried out as a pre-test / post-test control group experimental design study in 82 patients in the general surgery clinic of a university hospital in Istanbul

Conditions

Postoperative Pain; Postoperative Wound Complication

Outcome Measures

Primary Outcomes (3)

• Postoperative pain intensity

  Pain intensity assesment with Visual Assesment Scale (VAS) Score: 0-10; 0- No pain, 10- Worst pain

  Reported pain severity in the first 24 hours after surgery.

• Change from Postoperative Neck Pain and Disability at 1 month

  Neck Pain and Disability Scale (NPDS) The scale consists of 15 items. Each item measures the severity of pain, and evaluates the interaction of professional, social and functional aspects of life, and the presence and extent of emotional factors. Each item has a 10 cm visual analog scale. It is divided into 6 sections at equal intervals by vertical bars. Each item is between 0-5 points.

  Postoperative 1 st week and 1 st mounth

• Change from Postoperative Wound Healing at 1 month

  Patient and Observer Scar Rating Scale (POSAS) The scale consists of 7 items, 6 of them are for evaluating the scar (pain, itching, color, elasticity, thickness and irregularity assessment) and 1 evaluating the general opinion about the scar. Each item has a Likert-type score ranges from 1 to 10. 1 indicates normal skin, 10 indicates worst scar assessment. The lowest score in scale, which is 6, demonstrates normal skin, the highest score 60 demonstrates the worst possible scar. The scale score is calculated over the first 6 items.

  Postoperative 1 st day, 1 st week and 1 st mounth

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Routine nursing care (use of analgesics, IV fluid therapy and wound care) was applied to patients in experimental group after thyroidectomy. A brochure was developed in line with the literature on head-neck stretching exercises. Since the patients came to the clinic on surgery day, the exercises were examined by the patient on the first postoperative day. The patient was asked to perform the exercises 3 times a day, in the morning, noon and evening for a month, provided that each movement was 5 times. Then, the "Patient and Observer Scar Rating Scale (POSAS) " was applied. The pain level of the patient on postoperative day 1 was evaluated using VAS. For further evaluations, the patient was called by phone at the 1st week and 1st month. Neck pain and discomfort status was evaluated with the "Neck Pain and Disability Scale" (NPAD), and then the scar appearances with the "Patient and Observer Scar Assessment Scale" by requesting neck photographs at the 1st week and 1st month.

Other: head-neck stretching exercises

Control Arm

NO INTERVENTION

Routine nursing care (use of analgesics, IV fluid therapy and wound care) was applied to the control group after thyroidectomy. Follow-up of the patients with the scales applied in the experimental group were also performed to the control group at the same intervals. After thyroidectomy, patients were called by phone in the 1st week and 1st month. "Neck pain and discomfort scale" and "Patient and Observer Scar Rating Scale" were applied again in both phone calls. Photographs of the scar appearance at the 1st week and the 1st month were requested from the patients.

Interventions

head-neck stretching exercises OTHER

Neck stretching exercises which include basic movements of the neck are simple and effective exercises. Stretching exercises provide neuromuscular coordination and flexibility in patients by reducing pain and muscle weakness (Nakamura, Kodama, and Mukaino 2014). For this reason, neck stretching exercises should be performed in early postoperative period and a nurse should teach the patient the head-neck stretching exercises and ensure the patient's comfort after thyroidectomy.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having agreed to participate in the research verbally and in writing after being informed about the research,
• years of age or older,
• Patients who were able to understand the information given, who could read, write and speak in Turkish, who have not any problems preventing verbal communication, and who underwent thyroid surgery were included in the study.

You may not qualify if:

• \- Patients who suffers from cervical problems before surgery were excluded from the study.

Sponsors & Collaborators

• Acelya Turkmen: lead

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Nihat AKSAKAL, Assoc. Prof. Dr

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant PhD

Model Details: A randomized controlled experimental study to determine the effect of post-thyroidectomy head-neck stretching exercises on postoperative pain level and wound healing

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 23, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: August 12, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)