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

NCT ID: NCT04680754

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Postoperative Wound Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

head-neck stretching exercises

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acelya Turkmen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Acelya Turkmen

Research Assistant PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nihat AKSAKAL, Assoc. Prof. Dr

Role: STUDY_CHAIR

Istanbul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cukurova University

Adana, Sarıcam, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/1763

Identifier Type: -

Identifier Source: org_study_id