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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04680754
Other study ID # 2018/1763
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date August 12, 2020

Study information

Verified date December 2020
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date August 12, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
head-neck stretching exercises
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.

Locations

Country Name City State
Turkey Cukurova University Adana Saricam

Sponsors (1)

Lead Sponsor Collaborator
Acelya Turkmen

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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
Primary 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
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