Postoperative PainNCT04680754
The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing
A study testing head-neck stretching exercises in people with Postoperative Pain and Postoperative Wound Complication, run by Acelya Turkmen at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Wound Complication
- What is being tested?
- head-neck stretching exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 12 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who suffers from cervical problems before surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- head-neck stretching exercises
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head-neck stretching exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity assesment with Visual Assesment Scale (VAS) Score: 0-10; 0- No pain, 10- Worst pain
Measured: 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.
Measured: 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.
Measured: Postoperative 1 st day, 1 st week and 1 st mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled experimental study to determine the effect of post-thyroidectomy head-neck stretching exercises on postoperative pain level and wound healing
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acelya Turkmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Acelya Turkmen, Cukurova University
- Investigators
- Nihat AKSAKAL, Assoc. Prof. Dr, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680754
- Sponsor's protocol ID
- 2018/1763
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing- Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04680754
- Acronym / sponsor ID
- 2018/1763
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Acelya TurkmenUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled experimental study to determine the effect of post-thyroidectomy head-neck stretching exercises on postoperative pain level and wound healing
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: head-neck stretching exercisesRoutine 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who suffers from cervical problems before surgery were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head-neck stretching exercisesNeck 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. | Other | Experimental Arm |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihat AKSAKAL, Assoc. Prof. Dr study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing head-neck stretching exercises in people with Postoperative Pain and Postoperative Wound Complication, run by Acelya Turkmen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: Reported pain severity in the first 24 hours after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.