Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06426381 |
Other study ID # |
ayse25 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 4, 2023 |
Est. completion date |
June 2024 |
Study information
Verified date |
May 2024 |
Source |
Ataturk University |
Contact |
Ayse ÇELIK |
Phone |
05417967629 |
Email |
ayse_25.25[@]hotmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to investigate the effect of therapeutic touch on patients' anxiety,
vital signs and comfort levels during knee replacement surgery performed under local
anesthesia.
The study will be completed with a total of 128 participants, including 64 experimental and
64 control participants.
As a randomization method, the simple randomization method will be used to ensure an equal
number of samples in two groups, and patients will be assigned to the experimental and
control groups. In the research, patients will be given verbal information about the
research, and written informed consent will be obtained from the patients who accept it.
In the study, therapeutic touch was applied for 15-20 minutes during knee replacement surgery
and the effect of this application on vital signs, anxiety level and comfort was evaluated.
Description:
Knee replacement surgeries are a common treatment method for patients with problems such as
pain and limitation of movement resulting from knee joint disorders. This type of surgery is
usually performed under general anesthesia, allowing patients to lose consciousness during
surgery. However, general anesthesia may have some risks and complications. For this reason,
local anesthesia has become increasingly popular.
Local anesthesia is a method of anesthesia used to numb the surgical area. In this method,
anesthesia is injected directly into the surgical area and the patient is awake and conscious
throughout the surgery. Local anesthesia may have fewer side effects and complications
compared to general anesthesia. However, the effects of emotional factors such as stress,
anxiety and discomfort experienced by patients during surgeries performed under local
anesthesia are still poorly understood .
The human body is surrounded by an aura and open energy fields. It is reported that when
these energy fields are balanced, the individual is healthy, and when they are irregular, the
individual experiences health problems. Asymmetric energy fields can be balanced using the
therapeutic touch method and treatment becomes easier. In this way, the person regains his
health or can be helped to regain his health. Nursing theorist Martha Rogers supports this
statement. Rogers defined human beings as an open system with a complex and interactive
energy field covering the entire universe. It is assumed that the energy surrounding humans
is in wave form and that changes in the human body are controlled by these energy
fluctuations. If the person has health problems, this manifests itself in the form of energy
blockages or rhythm disorders. By correcting these energy rhythm disorders discovered by the
nurse with the therapeutic touch method, the person's health problem can be treated. In
recent years, there has been increasing evidence that alternative approaches, such as
therapeutic touch, have positive effects on surgical outcomes. Therapeutic touch is a method
that aims to provide relaxation, calming and healing through physical contact. This method
can reduce patients' stress levels, relieve pain, and increase their overall comfort level.
However, there are limited studies on the effect of therapeutic touch on vital signs during
knee replacement surgery performed under local anesthesia.
Surgeries are widely used as a method of treating various health problems that require
medical treatment. Knee prosthesis surgeries are one of the frequently used surgical
interventions in the treatment of painful and limiting diseases of the knee joint. Although
such surgeries have the potential to significantly improve individuals' mobility and quality
of life, the stress, anxiety and physical discomfort that may occur during and after the
surgery can be a significant source of concern for patients.
Anxiety is a common psychological reaction before and after surgical interventions and is an
important factor affecting the surgical process. Patients may experience increased levels of
anxiety when faced with uncertainty about the results of surgery, possible complications, and
the recovery process. The importance of this situation is of great importance in terms of the
success of the surgery and the patients' ability to better manage the postoperative period.
Anxiety negatively affects the patient's comfort level after surgery and can prolong the
recovery process. Lack of comfort can lead to increased physical and emotional stress caused
by surgery. It is important to note that because therapeutic touch has the potential to
increase patients' relaxation, stress reduction, and overall comfort level, research has also
been conducted in this area. However, there is no definitive information about the effect of
therapeutic touch on the comfort level during knee replacement surgery performed under local
anesthesia.
The aim of this study is to investigate the effect of therapeutic touch on patients' vital
signs, anxiety and comfort level during knee replacement surgery performed under local
anesthesia. This study aims to offer an alternative approach to improve patients' quality of
life by continuing to improve the results of surgeries performed under local anesthesia. This
study aims to fill the gap in this field by investigating the effect of therapeutic touch on
vital signs, anxiety and comfort level during knee replacement surgery performed under local
anesthesia. The findings may guide clinical practice in providing an alternative approach to
improve surgical outcomes and reduce discomfort experienced by patients. It may also provide
basic information to evaluate the feasibility of therapeutic touch in other surgical
procedures under local anesthesia.
This study was conducted as an experimental randomized controlled study. This method was
preferred because it allows the situations and attitudes of the individuals in the group
selected as a sample, regarding a phenomenon or event, and to describe the phenomena and
events in their own conditions and as they are. In addition, in randomized controlled
studies, the factors that cause events and situations and the degree of influence of these
factors can be determined. In the study, therapeutic touch was applied for 15-20 minutes
during knee replacement surgery and the effect of this application on vital signs, anxiety
level and comfort was evaluated. The hypotheses created in the research are listed below; The
research was conducted in the orthopedics and traumatology room in the operating room
department of Atatürk University Training and Research Hospital between September 2023 and
June 2024.
The population of the research consists of patients who had knee replacement surgery between
September 2023 and February 2024. The sample of the research consists of patients who meet
the inclusion criteria between the specified dates. Cohen's standard effect sizes were used
as reference in the power analysis. In this case, in this study, for the t test in
independent groups where the effect of therapeutic touch during knee prosthesis surgery will
be compared on vital signs, anxiety and comfort levels, if the study is conducted with a
total of 128 participants in two groups with 64 participants in each group, 80% confidence
interval is 95% at a significance level of 0.05. It has been determined that power can be
achieved. As a randomization method, the "simple randomization method" was used to ensure an
equal number of samples in two groups, and the patients were assigned to the experimental and
control groups. In the study, patients were given verbal information about the research, and
written informed consent was obtained from the patients who agreed.
Four different forms were used to collect data in the study. The Anxiety and Comfort Scale,
which was determined as the data collection tool in the study, was chosen by the researcher
as it was deemed suitable for the purpose. Analyzes were carried out with the data obtained
to test the validity and reliability of the selected scale. In order to ensure that the data
collection tools do not pose an ethical problem, people with expertise on the subject were
consulted and it was ensured that they would not cause any problems. However, the scale
questions were reviewed in detail by the researcher and the consultant, and since an
application was actually made in the form of a Likert scale, leaving the selection decision
entirely to the participants refutes the idea that it is a manipulation. The forms used to
collect data are listed below;
1. Patient Introduction Form
2. Vital Signs Record Form
3. Spielberg State-Trait Anxiety Scale
4. Perianesthesia Comfort Scale (PCS) In order to conduct the research, firstly, approval
was obtained from the Atatürk University Faculty of Medicine Ethics Committee and
institutional permission was obtained from the hospital where the research was
conducted. Verbal consent was obtained from the patients before data collection, and
data collection forms were collected by the researcher in the orthopedics and
traumatology room in the operating room department by face-to-face interview. Patients
who accepted the study and met the criteria were included in the experimental/control
group by randomization.
In patients included in the experimental group; On the day of surgery, patients who met the
research criteria were met, the purpose of the study was explained, and their written consent
was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were
administered in the patient room using face-to-face interview technique. When the patient was
taken to the operating table, the Vital Signs Record Form was filled out. Then, therapeutic
touch was applied for 15-20 minutes during the surgery. After the procedure was completed,
the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia Comfort Scale
(PCS) were administered.
In patients included in the control group; On the day of surgery, patients who met the
research criteria were met, the purpose of the study was explained, and their written consent
was obtained. The Patient Introduction Form and the Spielberg State-Trait Anxiety Scale were
administered in the patient room using face-to-face interview technique. When the patient was
taken to the operating table, the Vital Signs Record Form was filled out. After the procedure
is completed, the Vital Signs Record Form, Spielberg State Anxiety Scale and Perianesthesia
Comfort Scale (PCS) will be administered. No procedure was applied to the control group.