- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04680754
The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing
The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing- Randomised Controlled Trial
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Thyroid hormones are responsible for many metabolic activities in human physiology. It increases the basal metabolic rate, affects protein synthesis and helps growth of long bones. However, when thyroid functions change in the human body, the individual can be negatively affected and some individuals may require surgical intervention. Thyroid surgery is a prominent treatment for goiter, hyperthyroidism, thyroid nodules or thyroid carcinoma.
It has been reported that the most important complications after thyroidectomy are laryngeal nerve damage and hypoparathyroidism. Therefore, patients generally suffer from uncomfortable symptoms such as neck pain, shoulder stiffness, difficulty moving shoulders, choking or pressing feeling. In addition, it is indicated that in the early postoperative period, patients experience limitation in neck movement and have a robotic walking style in order to prevent possible neck pain and protect the incision area. It is emphasized that these symptoms persist for a while after the operation and negatively affect the daily life of the patient.
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. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sarıcam
-
Adana, Sarıcam, Turkey, 01380
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having agreed to participate in the research verbally and in writing after being informed about the research,
- 18 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.
Exclusion Criteria:
- Patients who suffers from cervical problems before surgery were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm
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. |
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.
|
No Intervention: Control Arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain intensity
Time Frame: Reported pain severity in the first 24 hours after surgery.
|
Pain intensity assesment with Visual Assesment Scale (VAS) Score: 0-10; 0- No pain, 10- Worst pain
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Reported pain severity in the first 24 hours after surgery.
|
Change from Postoperative Neck Pain and Disability at 1 month
Time Frame: Postoperative 1 st week and 1 st mounth
|
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
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Change from Postoperative Wound Healing at 1 month
Time Frame: Postoperative 1 st day, 1 st week and 1 st mounth
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nihat AKSAKAL, Assoc. Prof. Dr, Istanbul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/1763
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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