Hand MassageNCT06756529
The Effect of Hand Massage on Pain, Anxiety, Fear and Nausea After Surgery in Children
A study testing hand massage in people with Hand Massage and Pain, run by Fatma Akıl at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of hand massage on postoperative anxiety, pain, fear, and nausea and vomiting after pediatric surgery. This is a randomized, controlled experimental study. The sample consisted of 107 sick children who underwent ingunial hernia surgery (control: 55; experimental: 52). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Hand Massage, Pain, Anxiety
- What is being tested?
- hand massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Are between the ages of 7-12,
- Pediatric patients who are scheduled for ingunial hernia surgery,
- Volunteers to participate in the research,
- Those whose families agree to participate in the research
- No communication problems (vision, hearing, mental),
- For patients in the experimental group; All patients who did not have an infectious disease on the hand skin (shingles, fungus, eczema, warts, calluses), local infection (abscess, etc.), open lesion/wound, scar tissue, edema, hematoma, recent fracture or dislocation were included in the sample.
Who cannot join
- Being outside the 7-12 age range,
- Pediatric patients for whom ingunial hernia surgery is not planned,
- Those who do not volunteer to participate in the research,
- The family does not agree to participate in the research
- Having communication problems
- For patients in the experimental group, patients with infectious diseases, lesions, open wounds, hematomas, fractures-dislocations on the skin of the hands were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to determine the effect of hand massage on postoperative anxiety, pain, fear, and nausea and vomiting after pediatric surgery. This is a randomized, controlled experimental study. The sample consisted of 107 sick children who underwent ingunial hernia surgery (control: 55; experimental: 52). Hand massage was applied to the sick children in the experimental group the day before the surgery, on the morning of the surgery and after the surgery.
Read the detailed description
Due to various diseases throughout their developmental period, children find themselves in an environment where painful procedures are performed that they have not experienced before, and they remain in the hospital due to their illnesses. Surgical procedures constitute a portion of children's hospitalizations. Being exposed to unknown tools and physically painful procedures, being away from the family, and being in a foreign environment are situations that cause the child and family to experience anxiety. Children's anxieties about illness and hospital cause negative consequences such as prolonged recovery time and increased need for pain and sedative medication. Children's fears and anxieties about injuries and medical procedures reduce compliance with the treatment process and cause treatment to be delayed or postponed. Excessive anxiety hinders children's effectiveness in coping with medical treatment and increases uncooperative behavior and negative emotions toward healthcare professionals. Anxiety and pain are considered two common problems experienced by children before and after surgery. Pain causes changes in the brain and makes future pain worse. It slows healing, impairs treatment, and causes medical problems. Untreated pain causes anxiety, depression, irritability, and fatigue. Pain is a common consequence of surgery worldwide, and unrelieved or poorly managed pain is a burden on the child, the healthcare system and society.
Many patients described nausea and vomiting as the most unpleasant surgery-related experience they had in the postoperative period, even more than pain. In particular, prolonged hospital stay leads to re-admission and therefore increased treatment costs. At the same time, it causes the time allocated for nursing care to be prolonged, causing negative reflections on work-time management and therefore on the quality of patient care. Therefore, early detection and prevention of postoperative nausea and vomiting is very important for the satisfaction of the child and family and the quality of care.
In the literature, many non-pharmacological applications such as letting sick children listen to music, virtual reality glasses, and games after surgery have been performed and their effects on parameters such as pain, nausea-vomiting, and anxiety have been examined. Although there are studies examining the relationship between postoperative hand massage and anxiety, pain, fear and nausea in children, they are limited. Therefore, the aim of this study is to determine the effect of hand massage on anxiety, pain, fear and nausea and vomiting in children who have ingunial hernia surgery and are hospitalized in the pediatric surgery clinic.
- Conditions
- Hand Massage, Pain, Anxiety, Fear, Nausea-vomiting, Child
- Being tested
- hand massage
- Keywords
- hand massage, pain, anxiety, fear, nausea-vomiting, child, nurse
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massageOther
Also called experimental group
Hand massage was applied to the patients before surgery, on the morning of surgery and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | group receiving hand massage Receives: Other: hand massage |
| control group | No intervention | Group without hand massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Scale
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
Measured: one day before surgery
State-Trait Anxiety Scale
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
Measured: the morning of surgery
State-Trait Anxiety Scale
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
Measured: 1st day after surgery
Wong Baker Pain Rating Scale
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Measured: one day before surgery
Wong Baker Pain Rating Scale
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Measured: the morning of surgery
Wong Baker Pain Rating Scale
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Measured: 1st day after surgery
Medical Fear Scale
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Measured: one day before surgery
Medical Fear Scale
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Measured: the morning of surgery
Medical Fear Scale
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Measured: 1st day after surgery
Baxter Nausea Facial Expressions Scale (BARF Scale)
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
Measured: one day before surgery
Baxter Nausea Facial Expressions Scale (BARF Scale)
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
Measured: the morning of surgery
Baxter Nausea Facial Expressions Scale (BARF Scale)
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
Measured: 1st day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand MassageStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Akıl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Akıl, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756529
- Sponsor's protocol ID
- Fatma
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage on Pain, Anxiety, Fear and Nausea After Surgery in Children
- ClinicalTrials.gov ID
- NCT06756529
- Acronym / sponsor ID
- Fatma
- Conditions
- Hand Massage, Pain, Anxiety, Fear, Nausea-vomiting, Child
- Keywords
- hand massage, pain, anxiety, fear, nausea-vomiting, child, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Fatma AkılUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 3 Jan 2025 (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.
This study was conducted to determine the effect of hand massage on postoperative anxiety, pain, fear, and nausea and vomiting after pediatric surgery. This is a randomized, controlled experimental study. The sample consisted of 107 sick children who underwent ingunial hernia surgery (control: 55; experimental: 52). Hand massage was applied to the sick children in the experimental group the day before the surgery, on the morning of the surgery and after the surgery.
Detailed description
Due to various diseases throughout their developmental period, children find themselves in an environment where painful procedures are performed that they have not experienced before, and they remain in the hospital due to their illnesses. Surgical procedures constitute a portion of children's hospitalizations. Being exposed to unknown tools and physically painful procedures, being away from the family, and being in a foreign environment are situations that cause the child and family to experience anxiety. Children's anxieties about illness and hospital cause negative consequences such as prolonged recovery time and increased need for pain and sedative medication. Children's fears and anxieties about injuries and medical procedures reduce compliance with the treatment process and cause treatment to be delayed or postponed. Excessive anxiety hinders children's effectiveness in coping with medical treatment and increases uncooperative behavior and negative emotions toward healthcare professionals. Anxiety and pain are considered two common problems experienced by children before and after surgery. Pain causes changes in the brain and makes future pain worse. It slows healing, impairs treatment, and causes medical problems. Untreated pain causes anxiety, depression, irritability, and fatigue. Pain is a common consequence of surgery worldwide, and unrelieved or poorly managed pain is a burden on the child, the healthcare system and society.
Many patients described nausea and vomiting as the most unpleasant surgery-related experience they had in the postoperative period, even more than pain. In particular, prolonged hospital stay leads to re-admission and therefore increased treatment costs. At the same time, it causes the time allocated for nursing care to be prolonged, causing negative reflections on work-time management and therefore on the quality of patient care. Therefore, early detection and prevention of postoperative nausea and vomiting is very important for the satisfaction of the child and family and the quality of care.
In the literature, many non-pharmacological applications such as letting sick children listen to music, virtual reality glasses, and games after surgery have been performed and their effects on parameters such as pain, nausea-vomiting, and anxiety have been examined. Although there are studies examining the relationship between postoperative hand massage and anxiety, pain, fear and nausea in children, they are limited. Therefore, the aim of this study is to determine the effect of hand massage on anxiety, pain, fear and nausea and vomiting in children who have ingunial hernia surgery and are hospitalized in the pediatric surgery clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: hand massagegroup receiving hand massage |
| control group | No intervention | –Group without hand massage |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Are between the ages of 7-12,
- Pediatric patients who are scheduled for ingunial hernia surgery,
- Volunteers to participate in the research,
- Those whose families agree to participate in the research
- No communication problems (vision, hearing, mental),
Key exclusion criteria (6 listed)
- Being outside the 7-12 age range,
- Pediatric patients for whom ingunial hernia surgery is not planned,
- Those who do not volunteer to participate in the research,
- The family does not agree to participate in the research
- Having communication problems
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 |
|---|---|---|
| hand massageAlso: experimental groupHand massage was applied to the patients before surgery, on the morning of surgery and after surgery. | Other | experimental group |
Primary outcome
State-Trait Anxiety Scale
Time frame: one day before surgery
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
State-Trait Anxiety Scale
Time frame: the morning of surgery
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
State-Trait Anxiety Scale
Time frame: 1st day after surgery
This scale, consisting of 20 items, aims to evaluate the relationship of parameters such as tension, uneasiness, anxiety, and irritability with state anxiety. If the child indicates the presence of these parameters as 'a lot', 3 points are given, if the child indicates 'little', 2 points are given, and if the child indicates that they are not present at all, 1 point is given. The total score obtained from each scale is between 20-80.
Wong Baker Pain Rating Scale
Time frame: one day before surgery
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Wong Baker Pain Rating Scale
Time frame: the morning of surgery
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Wong Baker Pain Rating Scale
Time frame: 1st day after surgery
It contains a total of 6 facial expressions. Scoring is made between zero and five. "I have no pain", "I have mild pain", "I have moderate pain", "I have a lot of pain", "I have severe pain" and "I have severe pain" and "I have no pain" corresponding to each score, starting from the low score. With the expressions "I have very severe pain", the facial expression shape that is close to the patient's facial expression is determined and scoring is made according to this determined shape.
Medical Fear Scale
Time frame: one day before surgery
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Medical Fear Scale
Time frame: the morning of surgery
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Medical Fear Scale
Time frame: 1st day after surgery
This scale is a three-choice Likert type scale. For each question on the scale, a person is asked to choose one of the options "I am not at all afraid (1), I am a little afraid (2), I am very afraid (3) and the scale score is calculated. The lowest score on the scale is 27 and the highest score is 87. Children with a score between "0-29" are considered as less afraid, children with a score between "29-58" are considered as slightly afraid, and children with a score between "58-87" are considered as very afraid.
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time frame: one day before surgery
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time frame: the morning of surgery
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
Baxter Nausea Facial Expressions Scale (BARF Scale)
Time frame: 1st day after surgery
This scale, consisting of 6 different facial expressions, is evaluated between 0-10 points and there are two points between each facial expression.
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 3 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand massage in people with Hand Massage and Pain, run by Fatma Akıl 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 6 inclusion and 6 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 3 Jan 2025. 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?
State-Trait Anxiety Scale (time frame: one day before surgery). The study lists 12 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 3 Jan 2025.